Hunter Healthcare · 1 week ago
Associate Director of QMS and Vendor Management Quality
San Francisco, CA
Full-time
Hybrid
Lead/Staff, Director/Executive
8+ years expHunter Healthcare is a fast-growing, clinical-stage biopharmaceutical company focused on transforming metabolic disorders through innovative therapeutics. They are seeking an experienced Associate Director of QMS and Vendor Management Quality to ensure the highest standards of quality across their clinical programs and oversee the company's Quality Management System and vendor management program.
Health CareHuman ResourcesRecruitingStaffing Agency
Hiring Manager
Sophie O'Neill
Responsibilities
Lead development, implementation, maintenance, and continuous improvement of the QMS in alignment with FDA, ICH, EMA, and other applicable global regulations
Establish and maintain core quality systems, including Deviation, CAPA, and Investigation Management, Change Control, Risk Management, and Audit and Inspection Management systems
Ensure QMS scalability to support IND, Phase 1/3, and future commercialisation activities
Design, implementation, administration, and continuous improvement of the Document Management System (DMS) and/or electronic Quality Management System (eQMS)
Work closely with Clinical Operations, Clinical Development, Non-Clinical, IT, Regulatory Affairs, Pharmacovigilance, and Quality teams to identify, assess, and resolve quality issues
Collaborate cross-functionally to promote a culture of quality and compliance
Author, review, and approve SOPs and quality documents in collaboration with functional stakeholders
Ensure inspection readiness and support regulatory inspections
Manage quality metrics and lead governance forums
Own the vendor qualification and oversight process
Manage Approved Vendor List, audit schedules, vendor files
Schedule, lead/perform audits, performance reviews, and vendor lifecycle oversight, as needed
Ensure appropriate QA provisions in contracts and Quality Agreements, as needed
Oversee validation and lifecycle management of GxP systems
Ensure compliance with 21 CFR Part 11, Annex 11, ALCOA+
Approve validation documentation (URS, IQ/OQ/PQ)
Conduct IT vendor audits and system reviews
Provide QA support across clinical, nonclinical, and CMC
Review applicable to functional operations deviations, CAPAs, investigations, and change controls
Support inspection readiness
Qualification
Required
Bachelor's degree in Life Sciences required; advanced degree preferred
8+ years of GxP QA experience
3+ years of vendor management and audit experience
Experience with computerized systems validation
Knowledge of FDA, EMA, MHRA, TGA, ICH, and 21 CFR Part 11
Excellent oral and written communication, collaboration, and auditing skills are desired
High attention to detail, excellent organisational skills, and the ability to work on multiple projects with tight deadlines are desired
Experience communicating with both domestic and international collaborators with an awareness of cultural diversity
Ability to build scalable programs
Preferred
Previous participation in regulatory agency inspections is preferred
Experience in small or start-up biotech environments is preferred
Company
Hunter Healthcare
Hunter Healthcare is an award winning resourcing business that places people at the epicentre of healthcare.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2021-11-04Acquired
Leadership Team
Ben James
Co-Founder & CEO
Damian Tatlow
Chief Development Officer
Company data provided by crunchbase