Quality Assurance Senior Manager
Fremont, CA · Full time
The Quality Assurance Senior Manager for Quality Operations will provide quality oversight of various Operations functions for Bionova Scientific West Warren site.
Duties & Responsibilities
Writes, reviews, and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc.
Participate as subject matter expert in deviation management investigations, CAPA and effectiveness check processes for continuous improvement and inspection readiness.
Performs review and approval for CAPAs, commitments, change requests, investigative protocols, and final reports.
Author, review and approve Change Control documentations for complex validation, equipment, facility/utility and/or automation changes.
Update Quality Management System (QMS) with improvements and fixes.
Leverage technical experience to streamline the review and oversight process to enable education of system users and assuring proper DI enforcement by being an SME on various systems and their capabilities.
Provide Quality oversight of commissioning and qualifications related to computerized system, utilities and/or software associated with GMP equipment to ensure compliance and adherence with BNS procedures, cGMP, and ISPE GAMP guidelines and regulations in collaboration with Validation, Engineering, Operation, Quality control, and external partners.
Review/Approve validation related system lifecycle documents (user requirements, functional and design specifications, qualification protocols/reports, plans, trace matrices, etc.) to support qualification projects as required per current Good Manufacturing Practices (cGMPs).
Review/Approve engineering, facilities, and quality documentations as needed.
Develop audit strategies for vendors and service providers used for GMP production.
Manage the life cycle of vendor qualification, comprised of initial vendor qualification and re-qualifications, maintaining an approved supplier/service provider list.
Completes training to become a qualified auditor and perform/assist in internal, customer and regulatory audits by preparing documentations associated with GMP Systems and processes.
Collaborates with other departments (Facilities & Engineering, Technical Operations, Clinical Operations, Quality Control, and IT) to ensure quality standards are in place.
Provides coaching and guidance to new personnel and to Quality Specialists who are training new personnel.
Facilitate a continuous improvement culture with other departments.
Perform other duties as assigned.
Bachelor's degree in Engineering, Life Sciences, or related discipline with 5+ years of relevant experience, or combination of experience and relevant advanced degree.
In-depth understanding of technical documentation
Flexible mindset for a dynamic environment.
Strong project management capabilities.
Ability to independently evaluate technical situations and propose potential solutions.
Ability to communicate clearly and professionally in writing and verbally.
Flexibility with work hours to meet business needs.
Strong analytical and problem-solving skills
Must be legally authorized to work in the United States without restriction.
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
Bionova Scientific is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.