Executive Director, Quality

This position is responsible for establishing and leading the Quality function at Context Therapeutics. The Executive Director of Quality will design and implement a phase-appropriate, risk-based Quality Management System (QMS) that ensures compliance with global GxP standards and supports the company's growth from early clinical development through pivotal trials and commercial readiness. You will serve as the senior-most quality authority, providing strategic oversight and hands-on leadership across clinical, non-clinical, and manufacturing quality in a CDMO/CRO-reliant business model.

This role requires balancing system build-out with day-to-day operational support, ensuring patient safety, data integrity, and regulatory compliance.

This position is based out of our headquarters in Philadelphia, PA with at least 2 days per week in the office.

Responsibilities

Job Responsibilities include, but are not limited to:

* Serve as the company's in-house expert on all GxP quality matters (GMP, GCP, GLP) and regulatory compliance.

* Define and implement a fit-for-purpose QMS, including SOP governance, document control, training programs, deviation/CAPA management, change control, and audit readiness.

* Lead quality oversight of CDMOs and CROs, including vendor qualification, technical/quality agreements, performance monitoring, and risk-based audits.

* Act as the primary quality representative on cross-functional teams (Clinical, Non-Clinical, CMC, Regulatory, Supply Chain) to ensure quality requirements are integrated into development plans.

* Oversee clinical trial quality compliance, including protocol review, site qualification, monitoring plans, data integrity, pharmacovigilance, and ethics/regulatory submissions.

* Manage GMP compliance for investigational medicinal products (IMPs), including batch record review, lot disposition, stability programs, packaging/labeling, and EU QP certification, where applicable.

* Develop and maintain inspection readiness for FDA, EMA, and other global authorities; lead internal audits and coordinate external vendor audits.

* Establish and track quality metrics and KPIs; lead periodic management reviews and continuous improvement initiatives.

* Provide strategic input to senior leadership and the Board on quality risks, regulatory trends, and organizational readiness.

* Hire, coach, and mentor quality staff as the organization grows; foster a culture of quality-first thinking across all functions.

Requirements

* Minimum 12 years of experience in pharmaceutical/biotech quality roles, with 7+ years managing teams.

* Prior experience at Director or Senior Director level in large pharma or experience supporting late-stage and commercial programs strongly preferred.

* Proven ability to build and scale QMS; expertise in CDMO/CRO oversight and inspection readiness.

* Deep knowledge of GMP, GCP, GLP, and global regulatory frameworks (FDA, EMA, ICH Q9/Q10); biologics experience highly desirable.

* Strong leadership, communication, and influencing skills; ability to operate strategically while remaining hands-on.

* BS in life sciences required; advanced degree preferred.

* Domestic and international travel as needed.

About Context Therapeutics

Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging ("TCE") bispecific antibodies for solid tumors. Context is building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 bispecific antibody, CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody. Context is headquartered in Philadelphia

Context Therapeutics is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.