Associate Director, Shift Quality Operations (Cell and Genetic Therapies)

Vertex Pharmaceuticals Inc (US); Tallahassee (FL); On-site; USD 154,000 - 231,000; Full time

Job summary

Vertex Pharmaceuticals Inc. is seeking an Associate Director – Shift Quality Operations to provide on-site quality leadership for cell therapy manufacturing across assigned shifts.

You will ensure compliance with cGMP and aseptic processing requirements, support batch disposition, investigations, and line clearance, and lead a team of quality professionals on the shop floor. The role requires a Bachelor’s degree in a related field and 8+ years of experience in biotech quality, with strong

Qualifications

• Bachelor’s degree required in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related discipline.
• 8+ years in biotech/regulated pharma incl. aseptic manufacturing and quality control.
• Experience leading shift quality teams and ensuring inspection readiness.

Responsibilities

• Provide shift-based QA oversight for aseptic manufacturing, in compliance with cGMP and aseptic standards.
• Oversee degradation, investigations, and CAPA with timely closure in QMS.
• Lead and develop a team of shift quality professionals and ensure effective handoffs.
• Maintain ongoing inspection readiness and support audits and regulatory inspections.
• Collaborate cross-functionally with Manufacturing, QA, QC, MSAT, Engineering, Validation, and Supply Chain.

Skills

QA Oversight

cGMP

Aseptic Processing

Deviation Mgmt

CAPA

Data Analytics

Leadership

Risk Management

Regulatory Compliance

Education

Bachelor’s degree in Biotechnology/Related

Job description

General/Position Summary

The Associate Director – Shift Quality Operations is an advanced technical resource in the principles and application of quality assurance and compliance. The Associate Director provides quality leadership and oversight for manufacturing operations conducted across assigned shifts for cell therapy manufacturing. This role is responsible for ensuring ongoing compliance with cGMP, aseptic processing requirements, site quality systems, and regulatory expectations while enabling safe, reliable, and efficient manufacturing. The position partners closely with Manufacturing, Quality Assurance, Quality Control, MSAT, Engineering, Validation, and Supply Chain to support batch execution, deviation management, investigations, line clearance, contamination control, and continuous improvement. The Associate Director also leads and develops a team of quality professionals providing real-time shop floor quality oversight. This On-Site role is located at Vertex’s VMC

Key Duties & Responsibilities

Quality Oversight

Provide shift-based QA oversight for aseptic manufacturing operations, including formulation, filling, inspection, and supporting activities as applicable. Ensure manufacturing activities are executed in compliance with cGMP, GDP, site procedures, and aseptic processing standards. Serve as the primary quality representative for escalating critical quality issues appropriately. Support batch disposition readiness through review of manufacturing documentation, events, and quality observations. Demonstrated understanding of digital quality systems, data management, automation, and emerging AI technologies within regulated GxP environments. Responsible for using platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics to perform Quality oversight

Aseptic Operations Support

Oversee quality execution for critical aseptic operations, material flow and contamination control practices, line clearance, and cell therapy manufacturing including chain of custody and identity. Ensure adherence to Contamination Control Strategy (CCS) and aseptic behaviors on the manufacturing floor. Provide real-time decision-making support during quality events and atypical situations

Deviation, Investigation, and CAPA Management

Lead or support deviation triage, investigation, root cause analysis, impact assessments, and CAPA development. Ensure quality issues are documented, investigated, and closed in a timely and compliant manner. Identify recurring issues and drive sustainable improvements to prevent repeat events. Expertise in utilizing eQMS platforms for QMS activities

Team Leadership

Lead, coach, and develop a team of shift quality professionals. Establish clear goals, performance expectations, and development plans. Promote a culture of quality, accountability, inspection readiness, and continuous improvement. Ensure adequate shift coverage and effective handoff across shifts

Inspection Readiness and Compliance

Maintain a constant state of inspection readiness for aseptic manufacturing areas. Support internal audits, regulatory inspections, and client audits. Ensure observations are addressed promptly and effectively

Cross-Functional Collaboration

Partner with site leadership and cross-functional teams to support: Production schedule adherence Product quality Operational excellence Tech transfer/startup activities Process improvements Act as a trusted advisor on quality risk and compliance decisions

Required Education Level

Bachelor’s degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related discipline required. Preferred master’s degree or relevant comparable background

Required Experience

8+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment. 5+ years of experience supporting aseptic manufacturing, sterile operations, or parenteral production. Prior people leadership or supervisory experience strongly preferred. Experience with shop floor QA oversight in a commercial or late-stage clinical manufacturing environment preferred

Required Knowledge/Skills

Strong knowledge of: cGMP regulations Aseptic processing principles Annex 1, FDA sterile manufacturing expectations, and contamination control concepts Deviation/CAPA/investigation systems Batch record review Risk management and quality systems Ability to assess quality risk in real time and make sound compliance-based decisions. Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma. Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence. Critical Thinking and Problem Solving skills

Other Requirements

Up to 5% travel 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

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

On-Site Designated Flex Eligibility Status: 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-Onsite

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

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