What are the responsibilities and job description for the Quality Assurance Validation Manager position at Abzena?
Position Summary:
As part of the Abzena Quality Systems, you’ll be a proven team member with experience in working with high-performance teams, bringing a strong compliance understanding, technical expertise and project management skills to enhance our Quality Team. This role will provide quality oversight and ownership for the verification and validation of GxP facilities, equipment, utilities, and processes including cleaning. You’ll ensure activities involving the development, verification and/or validation of processes and cleaning are performed via Abzena internal controls and meet regulatory requirements.
Overall Responsibilities:
- QA accountability and oversight of the execution of the Abzena Validation Program efforts including GxP test methods, facilities, utilities, equipment, and process.
- Assist business partners with the development of validation plans and protocols
- Work with QA partners to ensure execution was performed
- Identify key areas of improvement supporting GxP validation efforts
- Reporting key matrixes to the current state-of-compliance through
- Support business partners in making sure that the defined methodology and approach for supporting qualification validation initiatives are performed with scientific, regulatory compliance and statistical validity (as applicable)
- Support projects teams as the Quality SME for review/approval of deliverables associated with equipment systems and processes. This includes the tech transfer, qualification, verification, validation and reverification activities
- Provide training to business partners to educate as needed to support validation, qualification and verification activities
- Ensure that there is adequate rationale defined for the closure of generated non-conformances, discrepancies and deviations associated with verification/validation execution efforts.
- Present and defend all Validation activities and documentation during regulatory / internal / customer audits. Participate in the response to regulatory audit observations, as required Assist and support QA Operations in the evaluation of risk assessments related to validated state of equipment and processes.
- Perform necessary review and approval of QA change management activities and reviews on changes to verification/ qualification and requalification applicable GxP procedures. General QA support for all functions and as needed for outside vendors.
- Demonstrated ability to work/collaborate within teams while interfacing with both internal and external colleague.
- Hire and develop validation support staff.
General Responsibilities:
- Operates to the highest ethical and moral standards.
- Complies with Abzena’s policies and procedures.
- Adheres to quality standards set by regulations and Abzena policies, procedures and mission.
- Communicates effectively with supervisors and colleagues.
- Ability to participate effectively as a team player in all aspects of Abzena’s business.
- Travels as needed between GMP facilities.
Qualifications/Skills Required:
- Bachelor’s degree in life sciences, or engineering with 8 to 10 years of experience in the biotech/or pharmaceutical industries
- Minimum of 5 years of previous leadership experience in a related field.
- Experience supporting equipment, instrument and system qualification activities in R&D, Clinical and Contract Manufacturing commercial organizations.
- Strong knowledge of calibration methodology, equipment, and instruments
- Experience in supporting cleaning and process validation campaigns
- Experience supporting Test Method Verification/Validation activities (preferred)
- Support change controls, deviations, investigations root cause analysis and CAPAs as required
- Demonstrate strong organizational and interpersonal skills, building relationships with effective communication, influencing, conflict resolution, critical thinking and problem solving with a keen attention to detail.
- Demonstrated ability to work/collaborate within teams while interfacing with both internal and external colleagues
- Advanced knowledge and demonstrated experience using Industry International Standards and Guides (USP/ EP/ ISO/ IEEE/ ASTM/ ISPE/ PDA) and applicable GXP FDA, Canada, European, ICH regulations & guidelines.
- Experience with internal and customer audits.
- Facilitate and support quality management projects for continuous improvement
- Strong verbal, written, and presentation skills, including internal customer management skills.
- Ability to change priorities in response to company demands while continuing to deliver results
FLSA: Exempt
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