Associate Director, GMP QA - Analytical Biologics

Job Description

The role is recognized as an expert internally in the principles and application of quality and regulatory compliance. The individual adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. This role is responsible for managing compliance data review in support of biologics development programs at Vertex. The role is also responsible for coordinating with Quality Disposition teams for review of development program product release testing and Certificate of Analysis approval.  This role will manage direct reports to execute the team’s responsibilities.

This position reports to Director, GMP Operations Quality. This role requires a minimum of 3 days onsite per week at our Boston, MA office.

Key Responsibilities:  The responsibilities of this role may include, but are not limited to, the following:

Manage Quality staff to collaborate with cross functional technical groups on product stability programs.

QA review of Analytical data in support of Clinical development programs.

Support all analytical related deviations and investigations, OOS, OOTs as applicable.  Lead Material Review Board discussions, as necessary

Issuance of Stability reports upon request

Review of RSS and Shipping Excursion Study Reports

Oversee and conduct method validation/ transfer data review, for Clinical reference standard programs.

Review and approve Method Validation and transfer Protocols/reports generated internally and externally.

Support investigations and QA guidance for complex investigations

Communicate any risks and gaps to management as known.

Coordinate with Quality Disposition teams to ensure review and reporting of product release data

Perform Compliance review of data in support of disposition of Clinical product

Resolve issues with CMO or internal technical teams

Support all analytical related deviations and investigations, OOS, OOTs as applicable

Approve Certificate of Analysis

Review and approve stability trend reports in a timely manner

Identify and discuss stability trends with management

Product Transition to Commercial / Registration to Validation / PAI Readiness

Evaluate CMO Quality Systems to ensure compliance with commercial expectations

Provide onsite support for critical batches

Test Articles Oversight

Review of Test Article production records

Review of Test article data

Approval of Test article C of A

Change Controls- execution

Owner /Assessor of Change controls

QA Approver work with technical teams to resolve gaps and approve change plans and classification

Supporting deployment of QMS (GMP Rep)

Generate Performance updates for presentation to QMT, QLT, EQLT as needed

Gap/Risk communication

Metric analysis

Participate on process improvement initiatives

Performance Management/ Individual Development/ Training

Goals development

Perform performance reviews

Create Individual Development Plans in conjunction with employee

Timely completion of training requirements prior to execution

Minimum qualifications:

Master’s degree and 5-8 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of relevant work experience, or relevant comparable background

Successful people management

Previous experience with product stability programs

Preferred Qualifications:

Analytical Experience preferred: Data review, deviation review, change control experience, and Quality System background helpful.

Demonstrate adaptability; think analytically with ability to conduct data analysis while paying attention to details

Broad GxP Knowledge with ability to communicate effectively, collaborate and think critically to support impact assessments

Ability to understand technical processes, Knowledge and application of risk management principles/ Risk Impact evaluation-aligning effort to level of risk

Facilitation/ Problem Solving /organizational, planning, etc./ RCA tools/methodology/ Technical writing

Working knowledge of GMP regulations and applicability to duties. Operational QA experience in analytical or manufacturing setting, interpretation and application of GMPs and applicable guidelines/guidance’s ex.  ICH, USP, etc. or other industry best practices ex. ISPE, WHO, etc.  Successful track record influencing cross functional teams Communication, Influencing, Relationship Management/conflict mgmt.

Questioning-Ability to understand and translate customer needs

In depth knowledge of GMP/GDP regulations and application

Strong Quality Systems experience/background, experience presenting to cross functional audience, Coordination and planning experience- Critical, analytical and Strategic thinking

Ability to assess impact across multiple procedures and systems

Cross functional collaboration, in-depth GMP knowledge, and experience in  Presentation/Facilitation/ Risk Mgmt

Experience in GMP activities: Previous working experience with ICH expectations for Stability Knowledge of analytical techniques and data review

Attention to detail/ Sense of urgency- ability to act quickly/Escalation process

Previous experience with method validation and transfer oversight

Previous CMO oversight experience: Broad GMP knowledge across lifecycle of the product

Ability to Negotiate and Collaborate with team members to achieve results

Preferred experience in conducting/hosting/participating in regulatory/vendor or internal audits.

Prior experience in inspection support roles/Knowledge of audit process/Project Management

Strategic thinking/Understanding of agency expectations/Broad GxP understanding

Good understanding of GLP standards. Previous experience and success navigating gray areas.

Support review of test article characterization data

Previous experience with Biomarker testing oversight helpful.

Previous regulatory submission review experience:

Detail oriented with good knowledge of regulatory agency requirements.

A broad level of GMP understanding and ability to collaborate cross-functionally in a team setting

Ability to think strategically with clear goals in mind.

#LI-LM

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:

$153,900 - $230,900

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:

Hybrid-Eligible Or On-Site Eligible

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 ApplicationAssistance@vrtx.com