VP, Quality Assurance

City Therapeutics•Cambridge, MA

8h•$340,000 - $360,000•Onsite

About The Position

City Therapeutics is seeking a senior quality leader to own the company’s quality assurance strategy and systems as its clinical-stage biopharmaceutical pipeline advances through regulatory and clinical milestones. The Vice President, Quality Assurance will design, implement, and continuously improve the Quality Management System and all quality assurance functions, ensuring development, manufacturing, and clinical activities comply with cGXP regulations, applicable guidance, and internal standards. As a member of the leadership team, this person will build a culture of quality and maintain continuous inspection readiness. The role provides enterprise-wide quality strategy and executive oversight of cGXP compliance, the QMS, quality risk management, and quality performance reporting. It leads inspection preparation and agency interactions, oversees supplier and external partner quality, and works cross-functionally with Clinical Operations, Regulatory Affairs, CMC, R&D, and Supply Chain. The VP also supports due diligence and integration planning for partnerships, licensing, and M&A as needed. The role is onsite at City Therapeutics’ Kendall Square offices five days per week. The company states that it can be flexible and supportive when individual needs arise. Compensation is a base salary range of $340,000 to $360,000, with eligibility for an annual bonus, equity compensation, and a competitive benefits package.

Requirements

Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field.
15 or more years of progressive Quality Assurance experience in the biopharmaceutical or pharmaceutical industry.
At least 5 years in a senior or executive leadership role.
Demonstrated experience building and scaling QA functions in a clinical-stage or growth-phase biopharmaceutical company.
Working knowledge of international regulatory frameworks, including EMA, ICH, and PMDA requirements.
Ability to influence cross-functionally, communicate effectively at the executive level, and drive organizational alignment.
Track record leading successful regulatory inspections and managing health authority interactions and responses.
Extensive experience managing CMO, CDMO, and CRO quality relationships and overseeing multi-site QA systems.
Hands-on expertise in GMP and GCP regulations, including FDA 21 CFR Parts 210, 211, 312, and 600, and ICH Q7, Q9, Q10, and E6(R2).

Nice To Haves

Advanced degree (MS, PhD, or PharmD) is strongly preferred.
Experience across multiple modalities, including biologics and/or cell and gene therapies.
Prior experience supporting a product through BLA/NDA approval and commercial launch.

Responsibilities

Define and lead the enterprise-wide Quality Assurance strategy, aligning it with regulatory requirements, industry best practices, and business objectives.
Lead quality risk management, proactively identifying risks and implementing mitigation strategies.
Build, develop, and retain a high-performing QA team, with clear roles, accountability, and career development pathways.
Champion a proactive quality culture and serve as the organizational authority on quality matters.
Establish and monitor quality KPIs, metrics, and dashboards, and report quality status and trends to executive leadership and the Board as appropriate.
Provide executive oversight of cGXP activities and compliance with applicable FDA, EMA, ICH, and international requirements.
Own and continuously improve the QMS, including SOPs, change control, deviation and CAPA management, document control, and training programs.
Drive continuous inspection readiness across sites and functions.
Collaborate with Regulatory Affairs to prepare and review quality sections of IND, BLA, NDA, and other regulatory submissions.
Lead QA during regulatory agency inspections and audits, managing inspection responses and commitments.
Establish and maintain vendor qualification and audit programs for CDMOs, CMOs, CROs, and critical suppliers.
Negotiate, review, and execute Quality Technical Agreements with external partners.
Partner with Clinical Operations, Regulatory Affairs, CMC, R&D, and Supply Chain to integrate quality requirements throughout the product lifecycle.
Support due diligence and integration planning for partnerships, in-licensing, and M&A transactions as needed.