I have a current opportunity for an Associate Director, Quality Assurance position focused on document control. The position will be based in upstate NY with a leading bio-pharmaceutical organization. For further information about this position please apply.
Key Responsibilities:
This position will have an oversight on the following: documentation work-flows, records issuance, inspection readiness activities and support, continuous improvement, project management, logistics and metrics.
- Setting departmental goals that aligns with the greater organizational goals while ensuring prioritization of work and projects
- Leading and providing continuously improvement of Document Control processes which ensures that performance and quality complies with regulatory standards and internal requirements
- Working closely with global counterparts to ensure there's a global alignment on processes, systems and procedures, unified communication to user areas, and identification of system enhancements
- Recognizing risks to operations, and partnering with the team and the greater business to identify and implement solutions to reduce the risk(s)
- Putting together the resourcing strategies to plan the operating budget, headcount budget and forecast to ensure maximum utilization of personnel to fulfill department objectives
- Reporting status of process performance and ensuring on-time and accurate metrics for presentation; includes weekly operations, Quality Operations systems metrics and Right To Operate
- Supporting business improvement projects
- Collaborating with department management to create inspection readiness program(s), champion an inspection ready mentality and ensure documentation generation and maintenance all supporting successful inspections
Key Qualifications:
- Bachelors Degree with a minimum of 10 years of experience in a cGMP environment.
- Pharma/Biotech industry experience preferred but open to medical device experience as well
- Must have people management experience and/or team leadership experience
- Strong understanding and technical knowledge in Document Control/Information and Records Management operations and methodologies
- Need to have a regulatory mindset; knowledge of regulations in other countries outside the US is helpful (but not required).
