Cell & Gene Therapy Quality Lead​/Sr. Quality Lead

6215 - Cell & Gene Therapy Quality Lead / Sr. Quality Lead

Description

Verista’s 500 expert team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision‑making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world‑class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

• Provide end‑to‑end quality systems oversight for Cell & Gene Therapy platforms, ensuring compliance with global GMP and ATMP regulatory requirements
• Lead comprehensive review and disposition of deviations impacting Cell & Gene programs, ensuring appropriate impact assessments, risk evaluations, and timely resolution
• Drive cross‑functional CAPA processes, facilitating structured root cause investigations and ensuring implementation of sustainable, risk‑based corrective and preventive actions
• Partner with Quality Operations and QISM teams to evaluate system‑level trends, identify recurring risks, and strengthen overall quality system effectiveness
• Oversee lifecycle management and periodic review of SOPs and controlled documents governing Cell & Gene Therapy platforms to ensure alignment with evolving regulatory guidance
• Serve as Quality SME during audits and regulatory inspections, coordinating documentation, responses, and inspection readiness efforts specific to advanced therapy programs
• Ensure robust governance of quality system elements critical to Cell & Gene Therapy
• Monitor and trend quality metrics to proactively identify compliance gaps and drive continuous improvement initiatives across the platform

• Bachelor’s degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field
• 7+ years of experience in GMP‑regulated pharmaceutical or biotechnology environments, with direct experience supporting Cell & Gene Therapy or other advanced biologics programs
• Strong expertise in deviation management, CAPA, change control, and quality risk management
• Experience supporting regulatory inspections (FDA, EMA, or other global agencies)
• Demonstrated ability to collaborate cross‑functionally across Quality, Regulatory, Technical Operations, and leadership teams
• In‑depth understanding of regulatory expectations for advanced therapy quality systems
• Ability to be on‑site in Boston, MA as needed (potential remote/hybrid work setup – local candidates preferred)

National (US) Range: $85,000 – $127,144 USD

The actual salary is dependent upon a variety of job‑related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

• High growth potential and fast‑paced organization with a people‑focused culture
• Competitive pay plus performance‑based incentive programs
• Company‑paid Life, Short‑Term, and Long‑Term Disability Insurance
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

Verista is an equal opportunity employer.

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.