Job Description
The Associate Director – GMP Operations (Compliance) is accountable for quality oversight of QMS system records (deviations, CAPA, and change controls) supporting cell and gene therapy programs throughout clinical and commercial development to commercialization. The Associate Director is an advanced technical resource in the principles and application of quality assurance and compliance, has experience inparticipating in cross-functional teams working with deviations, Root cause analysis and CAPAs, as well as developing and communicating department QMS metrics and leading internal Tier meetings such as investigation and change control review boards.
This position reports to the Director, GMP Manufacturing Technical Services - Quality.
This role is located at Vertex’s Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210.Monday to Friday.
Key Duties and Responsibilities:
- Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions
- Participates in cross-functional teams as an experienced Quality technical resource
- Assists Change Control owners with ensuring compliance to change procedure requirements, assesses and approves change controls
- Be the Quality triage and impact assessor of investigations/deviations, reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations.
- Ensures appropriate CAPA actions are identified and addressed.
- Maintains Quality Metrics to support process improvement activities
- Proactively identify, assess and mitigate risks and gaps to cross-functional quality systems and technical quality processes.
- Responsible for coordinating, facilitating and follow up on any QLT action items assigned.
- Supports audit programs and inspection readiness including assisting in preparation of audit responses for Cell & Gene Audits.
- Act as a trusted advisor by providing compliance guidance through collaborative review and partnering with business stakeholders and contract manufacturers.
- Execute improvements to QA operations processes.
- Participate/ lead Cell & Genetic Program and Quality projects and drive continuous improvement activities.
Knowledge and Skills:
- Demonstrated experience in Quality/Technical GMP manufacturing operation.
- Experience successfully leading event investigations, Root Cause Analysis and CAPA.
- In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; Biotech/Cell & Gene GMP regulations and applicability. (e.g. EU, FDA, ICH, USP, etc. or other industry best practices ex. ISPE, WHO, etc.).
- In depth knowledge in Celltechnology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
- Critical Thinking and problem Solving with ability to evaluate quality matters and make decisions utilizing risk based approach.
- Ability to independently influence and effectively communicate with business stakeholders.
- Strong leadership skills with the ability to thrive in a high throughput environment.
- Results driven and attention to detail to execute in a QA operational role.
- Excellent collaboration skills, and teamwork to partner within Quality and with stakeholders
Education and Experience:
- Bachelor's degree in a biotech/ Lifesciences field.
- Preferred Master's degree or relevant comparable background
- 8+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.Experience in Cell or Gene therapies is preferred
In this On-Site designated role, you will 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-AR1 #LI-Onsite
Pay Range:
$152,200 - $228,300
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.
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
