Job Description

General Summary:

The Manager of Quality Control will be responsible for supporting the oversight of QC external contract labs. The position will manage GMP release and stability activities in support of clinical and commercial programs, while ensuring compliance with SOP’s, policies and industry guidances. In addition, this role may support transferring/validating GMP analytical methods, establishment 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 Vertex 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 supporting Vertex’s early to late-stage clinical/commercial biologics programs. Responsibilities include, but not limited to, supporting the oversight of QC external contract labs, managing QC activities/programs such as release, stability, reference standard, analytical lifecycle management, specifications, spec settings, sampling plans, deviations, OOS/OOT investigations, root cause analyses, CAPAs.
• Support CDMO oversight on placebo, DS and DP QC testing activities. Ensure all activities are completed according to established timelines and quality standards. Perform document reviews, study designs, sample management, raw data reviews, risk assessment, sampling plan evaluation, trending analysis and etc.
• Plan, manage and communicate stability pulls and ensure stability testing occurs within specified testing windows. Establish/extend DS and DP shelf lives based on stability data and coordinate with internal stakeholders to ensure uninterrupted clinical and commercial supplies.
• Manage reference standard and critical reagent programs, including qualification, inventory, and bridging activities.
• Support method validation and transfer activities as required in accordance with ICH/EMA/USP/Ph. Eur. Guidelines and internal procedures.
• Work with CMC technical SMEs and Regulatory to prepare and review 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.
• Perform QC impact assessments as required on product temperature excursions occurred at clinical sites and storage depots.
• Develop, implement and improve internal QC systems, processes and procedures as required. Proactively manage QC gap analyses and SOP revisions for continuous improvement.
• Interact with internal cross-functional teams, including Analytical Development, AS&T, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Vertex network of external CMOs/contract labs to support company’s clinical and commercial programs.
• Help support audits and pre-licensure inspections at CDMOs/contract labs.
• May require business travels to CDMOs/Contract labs as needed.

Knowledge and Skills:

• Relevant QC and/or analytical development experience in biologics is required. Prior experience in device functionality tests is a plus.
• Strong knowledge in QC principles, concepts, industry practices, and standards.
• 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 in regulatory requirements and guidelines (ICH, CFR, FDA) with respect to biologics manufacturing and release/stability testing.
• Prior audit/inspection interaction experience desired.
• Extensive knowledge of cGMP regulations and guidelines.
• Demonstrated experience within QC functions associated with the GMP production and testing of biologics in clinical and/or commercial settings.
• Demonstrated ability to work independently and effectively to timelines in a virtual environment (i.e., internal partners, external CROs, CMOs, CTLs, etc.) and manage QC deliverables effectively.
• 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.

Education and Experience:

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

Pay Range:

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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.

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 ApplicationAssistance@vrtx.com