|Job Description||Director, Quality Assurance|
What is this role really like?
Reporting directly to the Senior Director, Quality Assurance, the Director, Quality Assurance will be responsible for the quality oversight and management of all GMP-related activities, the quality management of CMOs, and strategies to advance overall company quality and compliance. This is both a hands-on and strategic quality assurance role for a small, emerging company in the targeted oncology therapeutic space with clinical assets in early and registrational phase development (based on an FDA Accelerated Approval timeframe). This key position requires a team player with a highly motivated attitude that will promote and cultivate cross-functional area support within the company to achieve and maintain the required levels of standards of quality and compliance, appropriate for the Mirati company GxP paradigm in balance with Mirati external GMP vendors.
Major tasks and responsibilities will include but are not limited to the following:
- Manages, maintains, reviews, and approves SOPs and related process documentation for all functional areas, appropriate for the Mirati’s GMP program
- Ensures internal R&D QA GMP SOPs and procedures are written, adequate and kept current in conjunction with Mirati functional areas and external GMP vendors
- Establishes GMP Policies and Standards and provides GMP training to functional areas
- Manages Mirati GMP vendor qualification and oversight
- Ensures Quality Agreements are in place for external vendors
- Conducts and/or manages GMP vendor audits including maintenance of audit schedule and audit close outs
- Ensures Clinical Trial Materials (CTMs) are properly manufactured and released (eg, Mirati QA Unit release function), including review and disposition of GMP products and labels, including master and executed batch records, produced at Mirati-selected GMP CMOs
- Provides QA support for review of internal documents.
- Supports the R&D project teams and reviews CMC Sections for INDs and Marketing Applications (eg, NDAs, MAAs, etc)
- Executes and/or manages mock preapproval inspections (PAIs) for Regulatory
- Assists in overseeing inspection readiness program as required
- Oversees GMP vendors during regulatory inspections as required
- Provides Regulatory submission support as needed
What would a successful candidate look like?
- Minimum of B.S. in Biology, Chemistry, Nursing, Pharmacy, or related scientific field.
- Minimum of 10 years of increasing responsibility in pharmaceutical, GxP-related
- Quality environment
- Proven track record of establishing, developing, and managing the quality function and implementing phase-appropriate GMP quality and compliance functions to oversee company Phase 1-3 development programs in balance with external GMP vendors
- In depth knowledge of the applicable GMP regulations, FDA Good Clinical Practices, ICH Guidelines, FDA Regulations and Guidance; working knowledge of Computer System Validation.
- Experience working with CMOs and experience with vendor selection and management.
- Experience in dealing with regulatory authorities such as the FDA and other international regulatory authorities
- Auditing knowledge: understands the overall audit process including design, conduct and reporting, and corrective action follow up
- Small molecule IND through NDA experience
- Experience which includes small to medium size pharma is a plus
- Exceptional written and verbal communication skills
- Must possess the ability to effectively manage multiple projects
- Proven problem-solving skills
- Ability to adapt rapidly and change focus based on real time results and corporate priorities
- Ability to travel 10% as needed
- Management experience is a plus
- Companion diagnostic experience is a plus
- Commercialization experience is a plus oversee company Phase 1-3 development
Mirati is an Equal Opportunity Employer (EOE) – we celebrate diverse experiences and welcome applicants that meet the minimum requirements. All applicants must be legally authorized to work in the US without sponsorship.
This role is NOT open to agencies- please no emails or phone calls.