It’s an exciting time to join us!

The Andelyn Biosciences’ Quality Assurance group is seeking a motivated individual to join our growing team as an QA Validation Manager.

As a QA Validation Manager, will serve as the primary developer/executor responsible for the Validation Life Cycle program activities such as validation plans, protocols and reports that support the business needs of the company.  The position will 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.

 

Schedule: Full-time (Benefits Eligible) 

Location: 

Central Campus 

700 Children's Drive

Columbus, OH 43205 

 

Under the guidance and direction of the Associate Director of Quality Assurance, essential functions of the QA Validation Manager include at a minimum:

  • Collaborate with Quality, Manufacturing, Laboratory and Engineering groups to facilitate and drive validation execution and completion.
  • Plan, coordinate and manage site-specific validation project activities including protocol development/approval, work schedules and lifecycle documentation.
  • 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.            

 

Knowledge, Skills, and Education required: 

  • Minimum of 10 years’ experience GMP/Biopharmaceutical/Biotech Industry, 3-5 years specific validation experience in a pharmaceutical environment, QA pharmaceutical experience preferred
  • Bachelor’s Degree in a technical or scientific discipline or equivalent, in lieu of education 20 years' of relevant experience. 
  • 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.
  • Excellent verbal and written communication skills to all levels of the organization. Technical writing required.
  • Strong experience working in cross-functional team. Ability to influence, negotiate, manage conflict and collaborate.
  • Must demonstrate a “can-do” attitude. 
  • 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.

 

Minimum Physical Requirements:

  • There are very minimal physical requirements. 
  • One needs to be able to lift 20-30 pounds occasionally, bend, reach or balance (0-33% of the time).
  • Requires ability to aseptically gown or wear other PPE on regular basis.
  • Must be able to stand for extended periods.

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.

EOE M/F/Disability/Vet


Andelyn Biosciences is currently operating under Executive Order 14042 that requires that employees of federal contractors and its affiliates be vaccinated against COVID-19, with some limited exemptions under the law.  As Andelyn is both an affiliate and will be a federal contractor, proof of vaccination status will be required prior to first date of employment.  Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.


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