Title: Manager, QA Validation
Location: Columbus, OH (Can Provide Relocation)
A biotech leader is seeking a qualified validation candidate to be responsible for the Validation Life Cycle Program. The QA Validation Manager will be primarily responsible to oversee and support the qualification and validation of the manufacturing, laboratory and quality equipment and processes, and ensure that the systems and processes perform according to internal specifications, comply with current GMPs and are maintained in a validated state.
Responsibilities
- Contributes to the development, management and improvements of validation quality systems including associated policies, procedures, guidelines, and templates in the area of validation
- Support the team and proactively ensure that Validation Master Plans, qualification and validation protocols and reports are aligned with CFRs and regulatory, global and internal guidelines.
- Support through Quality Review performance of Qualification/Validation activities including material, process, equipment and cleaning validation.
- Provide expertise and support to regulatory inspections including quality representation on all activities / topics involving validation of the manufacturing process or environment.
- Review qualification/requalification packages for completeness and accuracy, sound rationale; compliance with validation policies and procedures and accurate data analysis.
- Provide the technical input to address validation deviations and provide assessments for change requests and identify qualification requirements to ensure compliance to GMP's and that the validated state is maintained.
- Executes initial and final quality review of associated change controls as well as final approval of periodic reviews.
- Provide and document training to personnel performing validation activities.
- Remain current with FDA guidance and requirements regarding validation; ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP.
Qualifications
- Minimum of 10 years' experience GMP/Biopharmaceutical/Biotech Industry, 3-5 years specific validation experience in a pharmaceutical environment, QA pharmaceutical experience preferred
- Operational knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211
- Demonstrated Project Management abilities to lead and manage several projects, meeting deadlines and use critical thinking skills to problem solve effectively.
- Experience with the authoring and execution of Quality documentation including validation documentation, technical protocols and/or technical reports.
- Experience with FDA, EMA inspection interaction.
- Strong experience working in cross-functional team. Ability to influence, negotiate, manage conflict and collaborate.
- Proficient in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint). Knowledge of application software such as Trackwise, SAP, preferred.
We can provide relocation, but the candidate must be authorized to work in the United States.
