Director, Quality Control

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The Director QC is responsible for QC laboratory operations to ensure timely completion of testing (e.g. drug product intermediates stability raw materials and microbiology/EM) that is performed in compliance with regulatory agencies cGMPs and other company policies and procedures. Responsible for managing the QC budget. The Director QC is also responsible for on time closure of Lab investigations and associated CAPAs. Oversee management and scheduling of multiple teams with varying functions and goals within the department.

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 cGMPs and other company policies and procedures.

• Defines departmental roles and accountabilities. Hires integrates and develops high quality talent capable of delivering against the departments 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 provide 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

Specific Knowledge Skills Abilities:

• 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.

Education/Experience/ Licenses/Certifications:

• Bachelors 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.

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If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 . Visit to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

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