Quality Control Manager- Chemistry Lab
Bristol-Myers Squibb
Quality Control Manager- Chemistry Lab
Job Description
Manage team and ensure cGMP compliance of the laboratory area and operations under responsibility. Create a positive and collaborative team environment and ensure that Bristol Myers Squibb standards are met. Manages performance and provides technical guidance, coaching, and support to team members. Assigns training requirements and monitors the training status of assigned team members. Support creation of team plans to ensure resources are properly allocated and utilized effectively. Ensures all equipment used for GMP testing is in a qualified state. Authors, reviews, and approves complex GMP documentation such as laboratory procedures, work practices, plans, protocols, and reports. Support and sustain Lean Lab initiatives such as 5S, deviation reduction, Right First Time, and inspection readiness. Actively participates in inspections by Health Authorities. Report metrics to monitor schedule progress and help identify risk areas. Supports budget definition and adherence to budget targets. Support purchase requisitions and purchase orders are managed as appropriate to ensure business needs are met in a timely manner. Collaborate cross-functionally and interdepartmental to define testing priorities, assign work to team members, and monitor progress on schedule. Ensure timely completion of stability samples compliant with company procedures. Perform final approval and disposition of QC results. Provides oversight of testing contracted to external laboratories. Support Deviations, Investigations and Change Control Management Ensures Deviations, CAPAs and Change controls are handled appropriately and in a timely manner. Initiates and/or implements changes in controlled documents. Work with impacted QC area functions to define appropriate and effective corrective and preventive actions (CAPAs). Ensure timely and compliant closure of QC deviations/investigations and CAPAs according to Bristol Myers Squibb procedures. Ensures that staff (including short duration and temporary contracts) are properly informed of hazards and trained to act. Supporting People with Disabilities BS or advanced degree in Chemistry, Biochemistry, Pharmacy, or relevant scientific discipline or equivalent combination of education, training and experience. Minimum 5 years of work experience in a GMP environment (pharmaceutical industry or similar field). Preferably in an Oral Solid Drug manufacturing facility. 3-4 years Quality Control Laboratory management experience preferred. Exceptional scientific and practical knowledge of analytical techniques (e.g., chromatography techniques (High-performance liquid chromatography, Ultra-performance liquid chromatography, Gas chromatography), Dissolution, UV/VIS, and IR techniques). Working knowledge of relevant US, EU. and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participation of regulatory inspections. Experience with Laboratory Information Management System (LIMS), Learning Management System (LMS) and Enterprise Resource Planning System and SAP preferred. Subject matter expert of Quality Control activities in the pharmaceutical industry with strong knowledge and interpretation of cGMP and Pharmacopeias requirements applicable to solid oral dose forms. Knowledge of Data Integrity and Good Documentation Practices. Work to improve efficiency through process improvements. Independent, adaptable, and highly motivated. Action-oriented and capable of setting priorities, managing timelines, and effectively managing changing priorities. Exceptional communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations. Ability to navigate through ambiguity and rapid growth and adapt to change the status quo. Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment. General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio) Fluent in English or French and professional command (minimum B2 level) of the second language (written and verbal)
About the Role/Company
- Bristol Myers Squibb standards are to be met in the laboratory operations
Key Responsibilities
- Manage team and ensure cGMP compliance of the laboratory area and operations
- Create a positive and collaborative team environment and ensure that Bristol Myers Squibb standards are met
- Manage performance and provide technical guidance, coaching, and support to team members
- Assign training requirements and monitor the training status of assigned team members
- Support creation of team plans to ensure resources are properly allocated and utilized effectively
- Ensure all equipment used for GMP testing is in a qualified state
- Author, review, and approve complex GMP documentation such as laboratory procedures, work practices, plans, protocols, and reports
- Support and sustain Lean Lab initiatives such as 5S, deviation reduction, Right First Time, and inspection readiness
- Actively participate in inspections by Health Authorities
- Report metrics to monitor schedule progress and help identify risk areas
- Support budget definition and adherence to budget targets
- Support purchase requisitions and purchase orders are managed as appropriate to ensure business needs are met in a timely manner
- Collaborate cross-functionally and interdepartmental to define testing priorities, assign work to team members, and monitor progress on schedule
- Ensure timely completion of stability samples compliant with company procedures
- Perform final approval and disposition of QC results
- Provide oversight of testing contracted to external laboratories
- Support Deviations, Investigations and Change Control Management
- Ensure Deviations, CAPAs and Change controls are handled appropriately and in a timely manner
- Initiate and/or implement changes in controlled documents
- Work with impacted QC area functions to define appropriate and effective corrective and preventive actions (CAPAs)
- Ensure timely and compliant closure of QC deviations/investigations and CAPAs according to Bristol Myers Squibb procedures
- Ensure that staff (including short duration and temporary contracts) are properly informed of hazards and trained to act
Required Qualifications
- BS or advanced degree in Chemistry, Biochemistry, Pharmacy, or relevant scientific discipline or equivalent combination of education, training and experience
- Minimum 5 years of work experience in a GMP environment (pharmaceutical industry or similar field)
Preferred Qualifications
- Preferably in an Oral Solid Drug manufacturing facility
- -4 years Quality Control Laboratory management experience
- Experience with Laboratory Information Management System (LIMS), Learning Management System (LMS) and Enterprise Resource Planning System and SAP
- Fluent in English or French and professional command (minimum B2 level) of the second language (written and verbal)
Skills Required
- Exceptional scientific and practical knowledge of analytical techniques (e.g., chromatography techniques (High-performance liquid chromatography, Ultra-performance liquid chromatography, Gas chromatography), Dissolution, UV/VIS, and IR techniques)
- Working knowledge of relevant US, EU, and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participation of regulatory inspections
- Subject matter expert of Quality Control activities in the pharmaceutical industry with strong knowledge and interpretation of cGMP and Pharmacopeias requirements applicable to solid oral dose forms
- Knowledge of Data Integrity and Good Documentation Practices
- Independent, adaptable, and highly motivated
- Action-oriented and capable of setting priorities, managing timelines, and effectively managing changing priorities
- Exceptional communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations
- Ability to navigate through ambiguity and rapid growth and adapt to change the status quo
- Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment
- General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
Additional Requirements
- Work to improve efficiency through process improvements
Locations
- Boudry, Switzerland
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
100,000 - 150,000 CHF / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Exceptional scientific and practical knowledge of analytical techniques (e.g., chromatography techniques (High-performance liquid chromatography, Ultra-performance liquid chromatography, Gas chromatography), Dissolution, UV/VIS, and IR techniques)intermediate
- Working knowledge of relevant US, EU, and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participation of regulatory inspectionsintermediate
- Subject matter expert of Quality Control activities in the pharmaceutical industry with strong knowledge and interpretation of cGMP and Pharmacopeias requirements applicable to solid oral dose formsintermediate
- Knowledge of Data Integrity and Good Documentation Practicesintermediate
- Independent, adaptable, and highly motivatedintermediate
- Action-oriented and capable of setting priorities, managing timelines, and effectively managing changing prioritiesintermediate
- Exceptional communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizationsintermediate
- Ability to navigate through ambiguity and rapid growth and adapt to change the status quointermediate
- Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environmentintermediate
- General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)intermediate
Required Qualifications
- BS or advanced degree in Chemistry, Biochemistry, Pharmacy, or relevant scientific discipline or equivalent combination of education, training and experience (experience)
- Minimum 5 years of work experience in a GMP environment (pharmaceutical industry or similar field) (experience)
Preferred Qualifications
- Preferably in an Oral Solid Drug manufacturing facility (experience)
- -4 years Quality Control Laboratory management experience (experience)
- Experience with Laboratory Information Management System (LIMS), Learning Management System (LMS) and Enterprise Resource Planning System and SAP (experience)
- Fluent in English or French and professional command (minimum B2 level) of the second language (written and verbal) (experience)
Responsibilities
- Manage team and ensure cGMP compliance of the laboratory area and operations
- Create a positive and collaborative team environment and ensure that Bristol Myers Squibb standards are met
- Manage performance and provide technical guidance, coaching, and support to team members
- Assign training requirements and monitor the training status of assigned team members
- Support creation of team plans to ensure resources are properly allocated and utilized effectively
- Ensure all equipment used for GMP testing is in a qualified state
- Author, review, and approve complex GMP documentation such as laboratory procedures, work practices, plans, protocols, and reports
- Support and sustain Lean Lab initiatives such as 5S, deviation reduction, Right First Time, and inspection readiness
- Actively participate in inspections by Health Authorities
- Report metrics to monitor schedule progress and help identify risk areas
- Support budget definition and adherence to budget targets
- Support purchase requisitions and purchase orders are managed as appropriate to ensure business needs are met in a timely manner
- Collaborate cross-functionally and interdepartmental to define testing priorities, assign work to team members, and monitor progress on schedule
- Ensure timely completion of stability samples compliant with company procedures
- Perform final approval and disposition of QC results
- Provide oversight of testing contracted to external laboratories
- Support Deviations, Investigations and Change Control Management
- Ensure Deviations, CAPAs and Change controls are handled appropriately and in a timely manner
- Initiate and/or implement changes in controlled documents
- Work with impacted QC area functions to define appropriate and effective corrective and preventive actions (CAPAs)
- Ensure timely and compliant closure of QC deviations/investigations and CAPAs according to Bristol Myers Squibb procedures
- Ensure that staff (including short duration and temporary contracts) are properly informed of hazards and trained to act
Tags & Categories
Quality Control Manager- Chemistry Lab
Bristol-Myers Squibb
Quality Control Manager- Chemistry Lab
Job Description
Manage team and ensure cGMP compliance of the laboratory area and operations under responsibility. Create a positive and collaborative team environment and ensure that Bristol Myers Squibb standards are met. Manages performance and provides technical guidance, coaching, and support to team members. Assigns training requirements and monitors the training status of assigned team members. Support creation of team plans to ensure resources are properly allocated and utilized effectively. Ensures all equipment used for GMP testing is in a qualified state. Authors, reviews, and approves complex GMP documentation such as laboratory procedures, work practices, plans, protocols, and reports. Support and sustain Lean Lab initiatives such as 5S, deviation reduction, Right First Time, and inspection readiness. Actively participates in inspections by Health Authorities. Report metrics to monitor schedule progress and help identify risk areas. Supports budget definition and adherence to budget targets. Support purchase requisitions and purchase orders are managed as appropriate to ensure business needs are met in a timely manner. Collaborate cross-functionally and interdepartmental to define testing priorities, assign work to team members, and monitor progress on schedule. Ensure timely completion of stability samples compliant with company procedures. Perform final approval and disposition of QC results. Provides oversight of testing contracted to external laboratories. Support Deviations, Investigations and Change Control Management Ensures Deviations, CAPAs and Change controls are handled appropriately and in a timely manner. Initiates and/or implements changes in controlled documents. Work with impacted QC area functions to define appropriate and effective corrective and preventive actions (CAPAs). Ensure timely and compliant closure of QC deviations/investigations and CAPAs according to Bristol Myers Squibb procedures. Ensures that staff (including short duration and temporary contracts) are properly informed of hazards and trained to act. Supporting People with Disabilities BS or advanced degree in Chemistry, Biochemistry, Pharmacy, or relevant scientific discipline or equivalent combination of education, training and experience. Minimum 5 years of work experience in a GMP environment (pharmaceutical industry or similar field). Preferably in an Oral Solid Drug manufacturing facility. 3-4 years Quality Control Laboratory management experience preferred. Exceptional scientific and practical knowledge of analytical techniques (e.g., chromatography techniques (High-performance liquid chromatography, Ultra-performance liquid chromatography, Gas chromatography), Dissolution, UV/VIS, and IR techniques). Working knowledge of relevant US, EU. and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participation of regulatory inspections. Experience with Laboratory Information Management System (LIMS), Learning Management System (LMS) and Enterprise Resource Planning System and SAP preferred. Subject matter expert of Quality Control activities in the pharmaceutical industry with strong knowledge and interpretation of cGMP and Pharmacopeias requirements applicable to solid oral dose forms. Knowledge of Data Integrity and Good Documentation Practices. Work to improve efficiency through process improvements. Independent, adaptable, and highly motivated. Action-oriented and capable of setting priorities, managing timelines, and effectively managing changing priorities. Exceptional communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations. Ability to navigate through ambiguity and rapid growth and adapt to change the status quo. Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment. General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio) Fluent in English or French and professional command (minimum B2 level) of the second language (written and verbal)
About the Role/Company
- Bristol Myers Squibb standards are to be met in the laboratory operations
Key Responsibilities
- Manage team and ensure cGMP compliance of the laboratory area and operations
- Create a positive and collaborative team environment and ensure that Bristol Myers Squibb standards are met
- Manage performance and provide technical guidance, coaching, and support to team members
- Assign training requirements and monitor the training status of assigned team members
- Support creation of team plans to ensure resources are properly allocated and utilized effectively
- Ensure all equipment used for GMP testing is in a qualified state
- Author, review, and approve complex GMP documentation such as laboratory procedures, work practices, plans, protocols, and reports
- Support and sustain Lean Lab initiatives such as 5S, deviation reduction, Right First Time, and inspection readiness
- Actively participate in inspections by Health Authorities
- Report metrics to monitor schedule progress and help identify risk areas
- Support budget definition and adherence to budget targets
- Support purchase requisitions and purchase orders are managed as appropriate to ensure business needs are met in a timely manner
- Collaborate cross-functionally and interdepartmental to define testing priorities, assign work to team members, and monitor progress on schedule
- Ensure timely completion of stability samples compliant with company procedures
- Perform final approval and disposition of QC results
- Provide oversight of testing contracted to external laboratories
- Support Deviations, Investigations and Change Control Management
- Ensure Deviations, CAPAs and Change controls are handled appropriately and in a timely manner
- Initiate and/or implement changes in controlled documents
- Work with impacted QC area functions to define appropriate and effective corrective and preventive actions (CAPAs)
- Ensure timely and compliant closure of QC deviations/investigations and CAPAs according to Bristol Myers Squibb procedures
- Ensure that staff (including short duration and temporary contracts) are properly informed of hazards and trained to act
Required Qualifications
- BS or advanced degree in Chemistry, Biochemistry, Pharmacy, or relevant scientific discipline or equivalent combination of education, training and experience
- Minimum 5 years of work experience in a GMP environment (pharmaceutical industry or similar field)
Preferred Qualifications
- Preferably in an Oral Solid Drug manufacturing facility
- -4 years Quality Control Laboratory management experience
- Experience with Laboratory Information Management System (LIMS), Learning Management System (LMS) and Enterprise Resource Planning System and SAP
- Fluent in English or French and professional command (minimum B2 level) of the second language (written and verbal)
Skills Required
- Exceptional scientific and practical knowledge of analytical techniques (e.g., chromatography techniques (High-performance liquid chromatography, Ultra-performance liquid chromatography, Gas chromatography), Dissolution, UV/VIS, and IR techniques)
- Working knowledge of relevant US, EU, and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participation of regulatory inspections
- Subject matter expert of Quality Control activities in the pharmaceutical industry with strong knowledge and interpretation of cGMP and Pharmacopeias requirements applicable to solid oral dose forms
- Knowledge of Data Integrity and Good Documentation Practices
- Independent, adaptable, and highly motivated
- Action-oriented and capable of setting priorities, managing timelines, and effectively managing changing priorities
- Exceptional communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations
- Ability to navigate through ambiguity and rapid growth and adapt to change the status quo
- Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment
- General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
Additional Requirements
- Work to improve efficiency through process improvements
Locations
- Boudry, Switzerland
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
100,000 - 150,000 CHF / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Exceptional scientific and practical knowledge of analytical techniques (e.g., chromatography techniques (High-performance liquid chromatography, Ultra-performance liquid chromatography, Gas chromatography), Dissolution, UV/VIS, and IR techniques)intermediate
- Working knowledge of relevant US, EU, and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participation of regulatory inspectionsintermediate
- Subject matter expert of Quality Control activities in the pharmaceutical industry with strong knowledge and interpretation of cGMP and Pharmacopeias requirements applicable to solid oral dose formsintermediate
- Knowledge of Data Integrity and Good Documentation Practicesintermediate
- Independent, adaptable, and highly motivatedintermediate
- Action-oriented and capable of setting priorities, managing timelines, and effectively managing changing prioritiesintermediate
- Exceptional communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizationsintermediate
- Ability to navigate through ambiguity and rapid growth and adapt to change the status quointermediate
- Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environmentintermediate
- General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)intermediate
Required Qualifications
- BS or advanced degree in Chemistry, Biochemistry, Pharmacy, or relevant scientific discipline or equivalent combination of education, training and experience (experience)
- Minimum 5 years of work experience in a GMP environment (pharmaceutical industry or similar field) (experience)
Preferred Qualifications
- Preferably in an Oral Solid Drug manufacturing facility (experience)
- -4 years Quality Control Laboratory management experience (experience)
- Experience with Laboratory Information Management System (LIMS), Learning Management System (LMS) and Enterprise Resource Planning System and SAP (experience)
- Fluent in English or French and professional command (minimum B2 level) of the second language (written and verbal) (experience)
Responsibilities
- Manage team and ensure cGMP compliance of the laboratory area and operations
- Create a positive and collaborative team environment and ensure that Bristol Myers Squibb standards are met
- Manage performance and provide technical guidance, coaching, and support to team members
- Assign training requirements and monitor the training status of assigned team members
- Support creation of team plans to ensure resources are properly allocated and utilized effectively
- Ensure all equipment used for GMP testing is in a qualified state
- Author, review, and approve complex GMP documentation such as laboratory procedures, work practices, plans, protocols, and reports
- Support and sustain Lean Lab initiatives such as 5S, deviation reduction, Right First Time, and inspection readiness
- Actively participate in inspections by Health Authorities
- Report metrics to monitor schedule progress and help identify risk areas
- Support budget definition and adherence to budget targets
- Support purchase requisitions and purchase orders are managed as appropriate to ensure business needs are met in a timely manner
- Collaborate cross-functionally and interdepartmental to define testing priorities, assign work to team members, and monitor progress on schedule
- Ensure timely completion of stability samples compliant with company procedures
- Perform final approval and disposition of QC results
- Provide oversight of testing contracted to external laboratories
- Support Deviations, Investigations and Change Control Management
- Ensure Deviations, CAPAs and Change controls are handled appropriately and in a timely manner
- Initiate and/or implement changes in controlled documents
- Work with impacted QC area functions to define appropriate and effective corrective and preventive actions (CAPAs)
- Ensure timely and compliant closure of QC deviations/investigations and CAPAs according to Bristol Myers Squibb procedures
- Ensure that staff (including short duration and temporary contracts) are properly informed of hazards and trained to act
Tags & Categories