Associate Director, GMP Operational Quality - Cell & Genetic Therapies

Vertex Pharmaceuticals Inc (US); Boston (MA); Hybrid; USD 157,000 - 235,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Medical, dental, vision

Job summary

Vertex Pharmaceuticals Inc. in Boston is seeking an Associate Director, GMP Operational Quality to oversee quality assurance activities, develop personnel, and ensure deliverables meet cGMP and regulatory requirements.

You will lead a Quality team, collaborate with partners, manage audits, CAPA, change controls, and support regulatory submissions while mentoring staff. Hybrid work options with on-site presence in Boston; total rewards include bonus and equity; 8+ years in pharma quality and 2+

Qualifications

• Bachelor's degree in a scientific or allied health field; typically 8+ years of work experience and 2 years of management experience.
• In-depth knowledge of global cGMP requirements and pharmaceutical quality systems.
• Demonstrated ability to manage complex projects/teams and mentor staff.

Responsibilities

• Lead a Quality team providing quality oversight and support to Vertex's business activities.
• Oversee QA responsibilities for Change Controls, GMP investigations and CAPAs.
• Prepare for inspections and support regulatory submissions as applicable.
• Partner with internal/external teams to resolve complex quality issues and drive improvements.

Skills

QA leadership

cGMP knowledge

project management

cross-functional collaboration

audits & inspections

CAPA/RCA

Change Controls

QDocs/Trackwise/Veeva

Education

Bachelor's degree in science

Tools

QDocs

Trackwise

Veeva

Job description

General Summary

Job Description General Summary: The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates group responsibilities to ensure timely delivery to support business, but mentors team members to provide individual development in addition to efficient and valuable service to project teams.

Key Duties and Responsibilities

Lead a Quality team: primarily responsible for providing quality oversight and support to business activities within purview at Vertex. Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions. Oversee CMO/Vendor performance, establishment of Quality Agreements and adherence of Quality Agreement terms. Enable team to achieve team goals/objectives and enable their individual career development. Develop and maintain compliant quality processes to support GMP activities. Oversee the QA support of Change Controls, GMP investigations and associated CAPAs. Track performance metrics and report to Sr Management; develops tactics to improve performance outcomes. Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections. Support review of regulatory submissions, as applicable. Lead continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources. Lead and follow up on any QLT action items assigned. Identify and communicate risks and assist with risk mitigation plans as necessary. Supports internal audit or external audit programs; assists in preparation of audit responses. Provide comprehensive knowledge support for partner and regulatory agency audits. Assist management team in budgeting and scheduling. Responsible for the following activities related to people management responsibilities: Talent Acquisition/ Recruiting/Interviewing/ Selection/Onboarding; Performance Management (goals, monitoring, reviews); Monitoring /Supporting Employee Engagement and Retention; Succession Planning; Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs. Accountable to provide oversight of day to day team operations. Assists with workforce planning/resource modeling and to update through forecasting activities.

Knowledge and Skills

In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturing. Demonstrated success in building high-performing teams and skilled at managing team and individual development. Strong management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness. Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives. Ability to independently lead cross-functional teams and represent the interests, strategies and objectives of Quality unit. Strong skills in mentoring staff and transferring technical knowledge to enable their capabilities and development. Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action. Demonstrated ability to evaluate complex quality matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions. Substantial experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA. Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections. Substantial experience with electronic document management systems (e.g., QDocs, Trackwise, Veeva).

Education and Experience

Bachelor's degree in a scientific or allied health field (or equivalent degree). Typically requires 8+ years of work experience and 2 years of management experience, or the equivalent combination of education and experience.

Pay Range

Pay Range: $156,600 - $234,800. 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 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 [e-mail]. Help Us Achieve Our Mission.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X. We believe our culture is one of Vertex's greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.