Sobre este puesto de Associate Director, Clinical Quality Assurance en Centessa Pharmaceuticals, LLC
Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions.
Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.
Description of Role
The Associate Director, Clinical Quality Assurance (CQA) will oversee GCP-focused quality assurance for Centessa-sponsored clinical trials (Early to Late Phase), ensuring compliance with global regulations, ICH guidelines, Centessa SOPs, and industry standards. This role leads daily clinical quality operations, maintains effective quality programs and documentation, and ensures GCP compliance and inspection readiness across all regulatory requirements.
Key Responsibilities
- Lead and maintain GCP QA programs, policies, and procedures.
- Serve as primary GCP QA expert and point of contact.
- Ensure clinical programs comply with global health authority regulations and ICH guidelines.
- Provide QA oversight for protocols, ICFs, CSRs, and other trial documents.
- Monitor evolving GCP regulations and communicate impact to stakeholders.
- Develop and execute global GCP audit strategies and annual plans.
- Conduct and manage audits of investigator sites, CROs, suppliers, systems, and documents.
- Prepare audit reports, evaluate CAPAs, and ensure effective follow-up.
- Lead inspection readiness activities and support regulatory inspections (e.g., FDA, EMA, MHRA).
- Partner with cross-functional teams to ensure compliance.
- Represent CQA on study teams and contribute to protocol design and risk management.
- Collaborate on procedures, forms, and templates related to clinical quality.
- Identify compliance risks and implement mitigation strategies.
- Investigate quality issues, perform root cause analyses, and drive CAPA resolution.
- Prepare and present KPIs, metrics, and audit status updates to leadership.
- Develop and maintain GCP-related SOPs, training materials, and quality metrics.
- Lead process improvement initiatives across QA and broader organization.
- Provide mentorship and leadership to QA staff; may include direct management
Qualifications
- BS or higher in Life Sciences, Chemistry, Pharmacy, or related field.
- 8–10 years of experience in pharmaceutical quality roles.
- Experience with document control software (e.g., ZenQMS, Veeva Vault, MasterControl) required.
Compensation
The annual base salary range for this position is $140,000.00 to $180,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge and location.
In addition to base pay, this role is eligible for a discretionary annual bonus. The Company also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.
Work Location
The Associate Director, Clinical Quality Assurance role is based in the US, with occasional travel.
POSITION: Full-Time, Exempt
EEOC Statement: Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.
