Director Quality Control

Biopharma Careers; Leiden; On-site; EUR 140,000 - 190,000; Full time

Job summary

Bristol Myers Squibb seeks a Director of Quality Control to lead all QC laboratory operations, ensuring timely testing across drug product, intermediates, stability, and raw materials in line with cGMP and regulatory standards. You will oversee multiple teams, drive CAPAs, manage the QC budget, and guide continuous improvement to deliver safe, high-quality medicines.

As a senior quality leader, you will partner with global QC networks, ensure inspection readiness, and align with site and network

Qualifications

• Advanced leadership, strategic thinking, critical reasoning, troubleshooting, and decision-making skills.
• Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills.
• Advanced knowledge of regulations and guidelines related to biopharmaceutical QC, including cGMP, ISO, FDA, MHRA, USP, and EP.
• Experience with method validation and technical transfer.
• In-depth knowledge of QMS and its application to the QC laboratory.
• Strong verbal and written communication skills tailored to varied audiences.
• Experience leading forecasting, capacity modeling, and resource planning.

Responsibilities

• Directs QC laboratory to ensure timely testing across drug product, intermediates, stability, raw materials, with regulatory compliance.
• Defines roles, hires, and develops talent to meet department goals.
• Sets performance objectives and monitors metrics to drive quality and efficiency.
• Manages lifecycle of analytical methods and technology within QC.
• Drives continuous improvement to improve turnaround time and cost of goods managed (COGM).
• Oversees operation and maintenance of laboratory equipment and data analysis/reporting of trends.
• Supports regulatory inspections, reviews, and approvals for site and products.
• Ensures on-time completion of quality records within the QMS.
• Oversees Annual Product Quality Review and investigation trending reports.
• Ensures compliance with BMS policies and harmonizes practices across sites.

Skills

Strategic leadership

Cross-functional collaboration

Regulatory knowledge

People management

Analytical thinking

Communication skills

Education

Bachelor’s degree in Chemistry or related science

Advanced degree preferred

Job description

At Bristol Myers Squibb, our employees often ask, \u201CWho are you working for?\u201D, a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

The Director Quality Control (QC) is responsible for leading all Quality Control laboratory operations, ensuring the timely delivery of testing activities, including drug product, intermediates, stability, raw materials, and microbiology/environmental monitoring. This role ensures that all testing is executed in compliance with applicable regulatory requirements, cGMP standards, company policies, and local procedures.

As a key quality leader, the Director QC oversees multiple laboratory teams with diverse functions, providing strategic direction, resource planning, performance management, and goal setting to drive operational excellence and continuous improvement. The role is accountable for ensuring the timely closure of laboratory investigations and associated CAPAs, while maintaining a strong culture of quality, compliance, and inspection readiness.

The Director QC also has full ownership of the Quality Control budget, ensuring effective financial stewardship, resource allocation, and investment decisions that support business objectives and future growth. Through strong leadership and cross-functional collaboration, this role plays a pivotal part in delivering safe, effective, and high-quality products to patients.

Duties/Responsibilities

• Directs QC laboratory to ensure timely completion of testing (e.g., drug product, intermediates, stability, raw materials) that is performed in compliance with regulatory agencies, cGMP, and other company policies and procedures.
• Defines departmental roles and accountabilities. Hires, integrates, and develops high-quality talent capable of delivering against the department’s goals and objectives.
• Establishes and communicates performance objectives for QC staff that are consistent with the business unit and Quality goals. Defines and monitors performance measures, provides developmental feedback and coaching, and creates a collaborative environment that attracts, develops, and retains the best talent.
• Accountable for lifecycle management of analytical methods and technology within the QC laboratory.
• Directs and participates in continuous improvement efforts to drive business efficiencies (e.g., TAT improvements, COGM reductions).
• Directs programs which assure the proper operation and maintenance of laboratory equipment and the timely data analysis and reporting of trends.
• Participates in the site team, which prepares for, hosts, and responds to regulatory inspections, reviews, and approvals of the facility and products.
• Accountable for on time completion of quality records within the QMS.
• Accountable for completion of Annual Product Quality Review and periodic investigation trending reports.
• Verifies compliance with applicable BMS Policies and Procedures and ensures consistency with other site procedures and/or specifications.
• Responsible for managing the QC Operations budget.
• Fosters collaboration and communication across site and network teams. Collaborates with managers across the QC network to harmonize best practices.
• Performs other tasks as required to support the QC laboratories.

Qualifications

• Ability to work independently and to collaborate cross functionally and at network level to drive operational and quality excellence.
• Advanced leadership, strategic thinking, critical reasoning, troubleshooting, and decision-making skills to resolve complex scenarios.
• Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills.
• Advanced knowledge of regulations and guidelines as related to the manufacture of cell therapy products e.g.: cGMP, ISO, FDA, MHRA, USP, and EP.
• Experience with method validation and technical transfer.
• In depth knowledge of QMS and its application to the QC laboratory
• Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences.
• Experience leading forecasting, capacity modeling, and resource planning.
• Bachelor’s degree required, preferably in Chemistry, Cell Biology, or related science. Advanced degree preferred.
• Minimum of 12 years of relevant work experience required
• Minimum 6 years of increasing management responsibility of a cell therapy, drug product, or related biopharmaceutical Quality Control laboratory.

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1605441 : Director Quality Control