VP, Quality Assurance

City Therapeutics•Cambridge, MA

20d•Onsite

About The Position

City Therapeutics, a clinical-stage biopharmaceutical company developing therapies for serious unmet medical needs, is seeking a senior quality leader to own the company’s quality assurance strategy and systems. The Vice President, Quality Assurance will design, implement, and continuously improve the Quality Management System and all QA functions, ensuring development, manufacturing, and clinical activities comply with cGXP regulations, applicable guidance, and internal standards. As a member of the leadership team, this executive will build a company-wide culture of quality and maintain continuous inspection readiness. The role provides executive oversight of cGXP compliance, quality risk management, the QMS, regulatory inspections and agency interactions, and quality oversight of vendors and external partners. The VP will lead and develop the QA team, establish quality metrics, and partner across Clinical Operations, Regulatory Affairs, CMC, R&D, and Supply Chain. The position is onsite five days per week at the company’s Kendall Square offices. The company says it will be flexible and supportive when individual needs arise. The base salary range is $340,000 to $360,000. The position is also eligible 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 of experience 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.
Strong leadership presence and ability to influence cross-functionally, communicate effectively at the executive level, and drive organizational alignment.
Proven 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.
Comprehensive, hands-on expertise in GMP and GCP regulations, including FDA 21 CFR Parts 210/211/312/600 and ICH Q7, Q9, Q10, and E6(R2).

Nice To Haves

Advanced degree such as an MS, PhD, or PharmD.
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 in alignment with regulatory requirements, industry best practices, and business objectives.
Lead quality risk management, identify potential risks, and implement mitigation strategies.
Build, develop, and retain a high-performing QA team, with clear roles, accountability, and career development pathways.
Champion a proactive quality culture across departments 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 ensure compliance with applicable FDA, EMA, ICH, and international regulations and guidance.
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.
Serve as the primary QA lead 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.