Associate Director, Quality Assurance

The Associate Director, Quality Assurance oversees the manufacture of clinical and commercial Drug Substance and Drug Product at domestic and international Contract Manufacturing Organizations (CMO) to ensure FibroGen products comply with current Good Manufacturing Practices (cGMPs) and are of the appropriate quality for their intended use.

The position leads the resolution of quality related issues with CMOs and with FibroGen’s Manufacturing, Analytical, Clinical, and Supply Chain functions.

The incumbent is also responsible for the review and approval of change controls, investigations & CAPAs and for final product disposition.

• Responsible for the Quality Assurance oversight of clinical and commercial manufacturing and packaging at domestic and international Contract Manufacturing Organizations (CMOs)

• Perform quality gap assessments internally and for CMOs as part of clinical / commercial CMO selection, management and inspection readiness

• Review and approve Technical Agreements with CMO’s and partners

• Review and approve internal and external investigations and CAPAs

• Review and approve OOS/OOE investigations and lab investigations

• Serve as a QA Lead for GMP investigations

• Review and approve change controls, master batch records, risk assessments, specifications, technical and validation protocols and reports

• Review and approve Product Specifications for bulk drug substance, drug product, and labelled product

• Review and approve Test Methods (including qualification) for bulk drug substance, drug product, and labelled product testing

• Function as the QA lead for technology transfers

• Track and present KPIs for Quality Operations

• Provide QA oversight of facility, equipment, instrument qualification internally and for CMOs

• Ensure timely release of Clinical Study Investigational Product and Commercial Product

• Manage temperature excursion process and determine final product disposition

• Lead QA Operations for assigned product(s) and back up Head of QA Operations when needed

• Manage and develop QA Operations staff

• Conduct and support GMP compliance audits of contractors and suppliers

• Establish and maintain strong working relationships with internal functional groups, contract manufacturers, and business partners.

• Conduct Product Complaint Investigations

• Review executed batch records for bulk drug substance, drug product and packaging operations and determine final product disposition as needed.

• Work with QPs to enable timely disposition of product to EU market.

• Function as the QA CMC lead and support the review of regulatory submissions.

• Author and negotiate Quality Agreements with CMO’s and partners

• Provide QA Subject Matter Expertise in support of Health Authority inspections at FibroGen and CMOs

• Author, review, and approve Standard Operating Procedures

• Lead Quality Systems improvements and special projects

• Provide QA support for QC, analytical and other cross-functional projects

• Participate in business review meetings

• Support the stability, process and method validation programs
Minimum requirements:

• Bachelor’s degree in chemistry, biology, microbiology or other related scientific discipline with 10+ years of GMP manufacturing experience in pharma/biotech/device industries

• Practical knowledge of global cGMPs and ability to apply sound judgment and risk based decision making skills

• Experience working with CMOs

• Working knowledge of API Manufacturing processes

• Working knowledge with CMC submissions

• Strong interpersonal and communication skills, self-motivated, independent, and collaborative

• Strong leadership and critical thinking skills with an ability to manage ambiguity
Department specific requirements:
This position is based in San Francisco and reports to the Head of Quality Assurance.

Must have good technical writing and project management skills as well as good working knowledge of Excel, Word, and PowerPoint.

Must have good knowledge of regulatory guidelines and ICH requirements for stability.

Must have working knowledge of basic statistics used for evaluation of stability data.

Travel to support supplier audits may be required (15 %).

FibroGen is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender identity/expression, creed, national origin/ancestry, age, alienage or citizenship, status, age, sex, sexual orientation, marital or domestic/civil partnership status, disability, veteran status, genetic information, or any other basis protected by law.

FibroGen will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.

FibroGen makes every effort to source and hire its staff through direct recruitment methods.

Employment opportunities at FibroGen are managed by our internal human resources team.

Please do not contact hiring managers or other FibroGen employees.

FibroGen does not accept unsolicited resumes from any source other than from the candidates themselves.

FibroGen does not accept unsolicited communications from external recruiters.

If there is a specific business need, a human resources team member will contact external recruiters directly.

An agency or independent recruiter must have a current, signed agreement and a work order for a specific position with FibroGen before presenting candidates and must be presented to human resources.

Submission of unsolicited resumes without a signed agreement and an applicable work order will not create an obligation on the part of FibroGen to pay a fee of any kind.

Posted 2 Days Ago

Full time

2021169

About Us

FibroGen, Inc.

is a leading science-based biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics.

The company applies its pioneering expertise in fibrosis and hypoxia-inducible factor (HIF) biology and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer.

Please visitwww.fibrogen.com to learn more about FibroGen where we believe that our employees are our most important asset and dedicated to remaining a great place to work.