Interview Travel Reimbursed
Associate Director, Quality Assurance & Auditing
If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals
Founded on the principle that strong science would lead to important new medicines, We have become an integrated biopharmaceutical company that discovers, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.
A high profile position in a rapidly growing biopharmaceutical company responsible for providing leadership and functional oversight for Quality Assurance & Auditing of clinical and pharmacovigilance operations. Individual will serve as part of a team in a fast-paced environment and will assist with overseeing the realization of industry best practices for GCP/GLP while remaining adaptable to the changing needs of the company. Individual will work closely with the GCP and GLP teams, assist with the develop processes and systems that drive compliance to critical regulatory requirements, and responsible for planning and conducting quality audits in assigned areas. This individual will need to have the ability to manage relationships, identify compliance issues and execute resolution in a highly autonomous manner.
•Collaborate with Management to ensure understanding and acceptance of the roles and responsibilities of the Clinical organizations as well as ensure acceptance of all quality processes and procedures.
•Provide guidance and direction on Quality matters.
•Promotes a GXP and Quality mindset at all levels.
•Creates and maintains a strong relationship with the leadership team and participates in all appropriate meetings and venues.
•Work with Clinical Management and Quality Management team to ensure continuity.
•Work with the Director of Quality Assurance & Auditing to ensure an appropriate strategy and execution for audits through defined processes and practices.
•Ensure visibility to and management of any noted deviations or deficiencies through trend and root cause analysis and works with the appropriate team and internal QA Staff to implement a CAPA system and processes.
•Fosters consistent Quality processes between the various divisions of clinical, pre-clinical and manufacturing.
•Ensures that all quality based deliverables are complying with regulatory and quality policies and procedures and timelines are met and observations are corrected.
•In collaboration with the Directory of Quality Assurance & Auditing, ensures that all the appropriate SOPs are in place and that the appropriate level of training and comprehensive has occurred.
•Manages staff as assigned to work with project teams on their quality deliverables.
•Ensures direct-report staff is appropriately resourced, supported and has the tools and direction to properly execute their function.
•Keeps current on changes to all regulatory requirements and, with other members of the Quality team, facilitates implementation into Regeneron systems.
•Coaches, develops and mentors direct reports.
•Ensures safety and operational standards are maintained.
•BS/BA or higher in life sciences; CQE not required, but a plus•A minimum of 10+ years experience in the pharmaceutical/biotechnology industry (biotech preferred)
•A minimum of 10+ years in auditing.
•Thorough knowledge of GxPs.
•Prior experience in a managerial capacity, as well as technical experience in a relevant operations function.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. In addition to being voted Best Place to Work in the Capital Region (Business Review, 2009) and receiving many other awards for being an exceptional employer, we offer an outstanding benefit package including immediate health benefits, stock incentives, 401k with company match, comprehensive relocation and immediate paid time off and paid holidays.
Contact Ken Karamani to discuss this role 203 698-3332
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