Sr. Associate / Manager, Quality Assurance Method Validation Position Description
- As part of a talented and multi-disciplinary team advancing an exciting novel approach to drug development, the Sr. Associate/Manager of QA Method Validation will provide quality oversight to support validation of GMP and GLP analytical test methods. Additional responsibilities may include oversight of analytical equipment qualification and/or validation of applicable computer systems.
- The successful candidate will be responsible for providing quality oversight of in-house and external analytical test method validation as the company progresses through early stage clinical trials. This is a hands-on role that requires close collaboration with Quality Control, Bioassay, Analytical Development, Bioanalytical, IT, and QA groups.
- Provide oversight of method validation from a Quality Assurance perspective to ensure quality and compliance requirements are met in an efficient and effective manner, and in support of corporate objectives and timelines.
- Provide quality oversight and approval of internal and external method qualification, including method validation project plans, protocols and reports.
- Provide guidance on method validation issues.
- Support investigation of analytical testing out-of-specification results and deviations during product testing.
- Act as the method validation SME for change controls supporting GMP/GLP systems.
- Ensure required Standard Operating Procedures and systems are implemented to support internal and external method validation programs for antibody intermediates, small molecule intermediates, antibody-drug conjugate drug substances and drug products.
- Provide quality oversight and approval of analytical equipment qualification and/or validation of applicable computer systems.
- Provide quality oversight and management of data integrity program.
- Report method validation/qualification quality issues and trends to management.
- Provide support for internal audits related to analytical equipment qualification and method validation.
- B.S. or advanced degree in chemistry, biology or related science with minimum of 8 years of experience in the pharmaceutical/biopharmaceutical industry and 4 years of direct experience supporting method validation activities from a quality assurance perspective.
- Excellent scientific background in and understanding of analytical and/or bioanalytical test methods. Scientific understanding of bioassay methods would be a plus.
- Knowledge in cGMP, GLP, USP, ICH guidelines, FDA method validation guidances, GAMP, Computer System Validation Lifecycle, MHRA Data Integrity, ERES and other applicable regulatory requirements.
- Proficiency in Softmax Pro, Empower, Watson LIMS and/or other applicable lab systems would be a plus.
- QA experience overseeing analytical method, system and/or computer validation activities.
- Ability to communicate effectively in a proactive and solution-focused manner.
- Ability to participate effectively on multi-disciplinary teams.
- Experience participating in internal audits as a method validation SME.
- Excellent interpersonal skills, organizational skills and both written and verbal communication skills including the ability to influence collaborators in other departments.
- Proven ability to operate in a fast-paced, multi-disciplinary environment, and adapt quickly to change to meet business goals and timelines.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.