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Senior Manager-  Quality Assurance and Regulatory Compliance: USA Application

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In this career changing opportunity, you will lead a Quality Team that is responsible for QA/QC oversight of deviations, change controls and CAPAs (Quality Systems) on the road to world class status.

Reporting directly to the Executive Director – Quality and Regulatory Affairs, the successful candidate will direct QA Operational activities at the Rochester, NY plant including management of QA Specialists and the QA Disposition Team.

You will define the scope, budget and timeline to analyze, revise, measure and report on the company’s audit preparedness as well as assume the lead role in all customer and regulatory audits. You will develop compliance staff, ensure QA resources are deployed/ managed effectively as well as own all Quality systems and Quality oversight in support of plant operations pertaining to internal and external audit processes.

The Role:

• Lead department, supervisory personnel and technical specialists in QA development, standards, documentation and compliance.
• Manage employee performance and provide team mentoring.
• Demonstrate strong level of influence in continuous improvement of quality assurance philosophy/ practices to ensure the highest standards are maintained.
• Conduct internal reviews to determine that the facility is thoroughly prepared for audits by regulatory bodies, customers, investors and global leadership.
• Utilize strategic and critical thinking to anticipate the compliance needs of the organization while maintaining compliant operations on a day-to-day basis.
• Is primary point person for customer/ regulatory audits ensuring that they run smoothly and demonstrates controls appropriately.
• Validate that deviation investigations are sound, meet current regulatory requirements and ensure product is safe and effective.
• Regularly updates senior management of product and process risks.
• Oversee complaints to be sure they are appropriately investigated in a timely manner and meet regulatory requirements.
• Ensure CAPA trends are identified, address root cause and reduce recurrence rates.
• Approve APRs and attests to relevancy, meet regulatory needs, and provide feedback to the organization regarding continuous improvement opportunities.
• Review and approve documentation such as procedures, protocols, reports as required by US and European regulations.
• Evaluate effectiveness of Standard Operating Procedures (SOP), identifies changes that would enhance the process, and ensures that all change control documentation is implemented.
• Identify the impact of available technology on business processes and ensures that it is used to maximum advantage.
• Focus on skill building and enabling direct team to promote quality and compliance across the manufacturing and support areas.
• Ensure stakeholders are appropriately trained on the process and any process changes.

The Candidate:

• Bachelor’s degree in Biology, Chemistry, Pharmacy or related field (Masters preferred) with a minimum 10 years of relevant experience in an FDA regulated environment and leadership background required.
• Demonstrable credentials interacting with regulatory authorities and direct experience within a contract manufacturing organization (CMO) is strongly preferred.
• Background in sterile processing/ handling as well as experience in blow-fill-seal (BFS) unit dose manufacturing is a plus.

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