Job Summary
The Senior Quality Manager will lead and manage the Quality department to ensure compliance with all applicable regulatory requirements and internal quality standards. This role is responsible for overseeing quality systems, driving continuous improvement initiatives, and supporting the development, manufacturing, and release of pharmaceutical products. The Sr. Quality Manager will play a critical role in maintaining inspection readiness and ensuring product quality, safety, and efficacy.
Primary Relationships
- Within Cristcot, the Sr. Quality Manager will collaborate closely with Manufacturing, Regulatory Affairs, Quality Control, Supply Chain, Commercial, and R&D teams.
- Outside Cristcot, the Sr. Quality Manager will engage with regulatory authorities (e.g., FDA, EMA, BIMO), contract manufacturers (CMOs), and third-party vendors.
The activities of the Senior Quality Manager will include, but are not limited to:
- Lead and manage the Quality department, including hiring, training, and performance management
- Ensure compliance with cGMP, FDA, EMA, ISO 13485 and other global regulatory requirements
- Oversee quality systems including CAPA, deviations, change control, and document management
- Function as the primary quality interface with CDMOs and testing labs.
- Drive issue resolution and ensure partners are inspection-ready
- Drive inspection readiness and lead internal audits
- Review and approve batch records, SOPs, change controls, methods, specifications, protocols and reports, and quality-related documentation
- Collaborate with cross-functional teams to support product development and commercialization
- Manage supplier quality and oversee vendor qualification processes
- Identify and implement continuous improvement initiatives within the quality system
- Monitor key quality metrics and report trends to senior leadership
- Ensure proper investigation and resolution of quality issues and complaints
Skills and Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field (advanced degree preferred)
- 8–12+ years of experience in pharmaceutical/biotech QA roles, with leadership responsibility
- Strong knowledge of cGMP regulations and global regulatory requirements
- Proven hands-on experience managing quality systems (batch review, CAPA, deviations, change control)
- Strong leadership, communication, and team management skills
- Ability to work cross-functionally in a fast-paced environment
- Experience with electronic quality systems (eQMS) preferred
- Strong analytical and problem-solving abilities
- Ability to travel up to 10–20% as needed