Quality Control Director Biologics

Job Description

General Summary:

The External Manufacturing Director – Quality Control (ExM-QC) will lead the strategic and technical oversight of Quality Control (QC) activities to ensure the highest standards of product quality and compliance for Vertex’s biologics and combination device product across development, PPQ, launch, and commercial lifecycle. This role is pivotal in driving QC excellence, fostering collaboration with internal and external stakeholders, and ensuring adherence to cGMP regulations. Reporting directly to the head of ExM-QC small molecule and biologics, the Director will play a critical role in shaping QC strategies, managing external partnerships, overseeing investigations and supporting regulatory submissions.

Key Duties and Responsibilities:

• Define and implement QC strategies and systems to ensure product quality and compliance for biologics and combination device products
• Ensure success of Quality Control function through strategic and scientific leadership. Develop and lead strong collaborative relationships with internal and external teams and build technical knowledge within the group
• Manage priorities and oversee QC related activities including lot release, stability studies, and OOS/OOT/deviation investigations at external testing sites.
• Provide technical and quality oversight to CTLs ensuring adherence to quality standards and project timelines through guidance, document review, audits, and issue resolution.
• Develop and monitor QC performance metrics and KPIs to drive continuous improvement.
• Oversee trending and statistical analysis of analytical data to support product shelf life and extensions
• Collaborate with internal cross-functional CMC/Quality teams to support control systems, quality management, comparability strategies, process development, regulatory strategies and other strategic planning
• Collaborate with Regulatory Affairs to review and author CMC sections for IND/IMPD and global regulatory submissions and to address information requests from regulatory agencies.
• Support digital initiatives to advance the quality system maturity from level 2 to level 3 through a cross-modality QA/QC forum
• Develop and manage QC budgets to align with organizational goals.

Knowledge and Skills:

• Demonstrated experience in biotech or pharmaceutical industry, in a senior analytical leadership role working with or in cGMP testing laboratories.
• Strong quality and compliance background in a commercial GMP environment with expertise in developing QC strategies, monitoring performance metrics, and driving continuous improvement initiatives.
• Demonstrated technical background in biologics and combination device products
• Solid project management skills and experience managing complex projects.
• Strong verbal and written communication skills: ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
• Strong leadership and an innate ability to collaborate and build relationships is critical.
• Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change
• Ability to travel, national and international, up to 20%

Education and Experience:

• M.S. or Ph.D. degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with 12+ years industry experience in analytical development and/or quality control in a pharmaceutical setting.
• Strong management and leadership skills.
• In-depth knowledge of QC principles, concepts, industry practices, and standards.
• Extensive experience in characterization, method development, validation, and transfer of non-compendial and compendial analytical methods for biologics using various techniques such as HPLC, CE, CIEF, MS as well as cell-based assays, potency assays, and device analytical testing
• Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) with respect to biologics manufacturing and release / stability testing.
• Extensive knowledge of cGMP regulations and guidelines

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

#LI-Hybrid
 

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]