Quality Control Senior Manager

Job Description

General Summary:

The Quality Control Senior Manager will be responsible for supporting the establishment and oversight of a new QC centralized external contract lab and management of existing contract testing labs. The position will manage GMP release and stability activities in support of clinical and commercial biologics programs while ensuring compliance with SOP’s, policies, and industry guidance. In addition, this role will help support the  transfer/validation of GMP analytical methods, participating in establishment and implementation of internal Quality Control systems, processes and procedures in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations. This role will interact with internal cross-functional teams and our network of external CMOs/contract labs to ensure that all GMP analytical methods for lot release and stability testing of drug substance and drug product biologics are implemented successfully.

Key Duties and Responsibilities:

• QC Subject Matter Expert for early to late-stage clinical/commercial biologics programs.
• Support the establishment and oversight of a new QC external centralized contract lab,
• Manage QC activities/programs such as release, stability, reference standard, method validation/transfer, method lifecycle management, specifications, spec settings, sampling plans, deviations, OOS/OOT investigations, root cause analyses, CAPAs.
• Manage relationship with contract testing lab – monitor business and quality KPIs and drive continuous improvement projects.
• Perform forecast analysis to ensure a continued analytical testing capacity.
• Help establish annual budgets to cover testing requirements.
• Manage and provide CDMO oversight on placebo, DS and DP QC activities.
• Ensure all activities are completed according to timelines and quality standards. 
• Perform document review, study design, sample management, data review, risk assessment and trending analysis. 
• Plan, manage and communicate stability pull dates and ensure stability testing occurs within specified testing windows. Establish/extend DS and DP shelf lives with internal stakeholders to ensure uninterrupted clinical supplies.
• Manage reference standard inventory and support qualification testing activities,.
• Manage reference standard selection, qualification, inventory, and bridging.
• Manage and ensure method validation and transfer activities are performed in accordance with ICH/EMA/USP/Ph. Eur. Guidelines.
• Work with technical SMEs and Regulatory to review and author QC related sections of IND, IMPD, BLA/MAA and global regulatory submissions and provide support in addressing information requests.
• Manage QC quality events such as OOS/OOT results, deviations and adverse stability trends.
• Manage cell bank, DS, DP, and placebo release and stability GMP specifications including justification of specifications and specification revisions.
• Perform QC impact assessments on product temperature excursions occurred at clinical sites and storage depots.
• Develop, implement and improve internal QC systems, processes and procedures. Proactively manage QC gap analyses and SOP revisions for continuous improvement.
• Interact with internal cross-functional teams, including Analytical Development, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Alpine’s/Vertex network of external CMOs/contract labs to support company’s clinical programs.
• Help support pre-licensure inspection and on-goings at CMOs/contract labs.

Knowledge and Skills:

• Strong knowledge of QC principles, concepts, industry practices, and standards.
• Experience in contract testing lab oversight. 
• Experience in characterization, method development, validation, and transfer of non-compendial and compendial analytical methods for biologics using various techniques such as HPLC, CE, icIEF, and mass spectrometry (MS), as well as biophysical characterization methods.
• Strong knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) with respect to biologics manufacturing and release/stability testing.
• Prior audit interaction experience
• Extensive knowledge of cGMP regulations and guidelines.
• Demonstrated experience and independence with QC functions associated with the GMP production and testing of biologics in clinical and/or commercial settings.
• Demonstrated ability to work effectively to timelines in a virtual environment (i.e., internal partners, external CROs, CMOs, CTLs, etc.) and manage QC deliverables.
• Experience contributing to product quality risk assessments to identify critical quality attributes and developing associated limits/specifications.
• Excellent written and verbal communication skills.
• Comfortable in a fast-paced company environment with minimal direction and able to prioritize and adjust workload based upon changing priorities.
• Travel Requirements: Travel to main office and CDMOs required (20% as required)

Education and Experience:

• B.S. or M.S. degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with 8+ years industry experience in analytical development and/or quality control in a pharmaceutical setting.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

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]