This role is a member of the Life Sciences group and Rockland Site Leadership team. The successful candidate will  join a great team and assure that the site remains under control with respect to GMP/ISO compliance, will collaborate with Operations to solve quality issues (as it applies to the site).  He/She will lead & support Audits & Regulatory Inspections at the Rockland site, direct staff in both QA and QC, support development of manufacturing and process controls and improve quality systems, provide hands-on support to product release and to address production concerns, support IQ/OQ/PQ activities, support customer requests as presented by Scientific Support/Product Manager, support Global Supplier Quality and site Procurement with management of Rockland suppliers. This role will oversee 4 direct reports.  

Primary Role Responsibilities:

• Serve as the site source for Quality/Regulatory-related expertise within the site and provide strategic leadership and management for the site`s Quality organization.
• Provide leadership to the Site Quality organization to ensure that teamwork, high morale,  innovation and continuous improvement are fundamental components of a world-class team.
• Develop and execute the Rockland Quality strategy commensurate with the overall site Quality Plan. Ensure alignment with customer needs and linkage with the overall Quality and business strategies.
• Implement continuous improvement initiatives to drive Quality programs and ensure maximum productivity.  Ensure systems meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
• Develop, implement and monitor Quality programs, policies and procedures to ensure compliance with GxP standards, ISO standards, corporate policies, FDA and other regulatory body regulations and guidelines (as applicable).
• Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction. Oversee all customer and regulatory authority audits and inspections and corrective action programs in response thereto
• Evaluate all current Quality systems and processes and recommend and implement appropriate enhancements to ensure the achievement of  long-term objectives
• Create active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Rockland Quality functions.
• Serve as the company Quality expert, providing solid, well-informed, actionable Quality support to Rockland Operations, R&D, and other functions as requested.
• Provide hands-on support for product release activities
• Perform other duties as assigned.

Structure:

The Quality Manager reports directly to the Global Quality Bioscience (dotted line to the Site Director, Rockland) and has been appointed as the Management Representative for the Rockland site.

1. This role is responsible for directing, monitoring, and managing the quality systems (including Management of Change, Document Control, Label Control, Complaint/Nonconformance, Internal Audits), and associated trainings.
2. This role assures the site remains in compliance with ISO 9001 and 21 CFR 820 (for the FDA listed class 1 medical device components). In addition, this position
3. is responsible for the coordination of corrective action from registrar audits, customer audits, and internal audits. This role is responsible for the Quality Control Lab and its activities.

This position has four direct quality reports: the QC Group Specialist, the Senior Quality Systems Specialist, and two Quality Control Scientists

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Skill and/or Education Requirements:

• Bachelor`s Degree in  a Life science, Engineering  or Quality Management or related science discipline

• 7+ years direct job related experience in an ISO/GMP facility manufacturing products with a minimum of 5 years’ experience in Quality Management
• Working knowledge of FDA cGMP requirements, and/or ISO 9000 standards; implementing and auditing these systems.
• Working knowledge of customer needs and product functions.
• Experience developing, coordinating and presenting training programs
• Computer proficiency in standard programs
• Excellent communication, written and oral
• Strict attention to detail
• Demonstrated Time / Priority management skills
• Demonstrated leadership abilities
• Demonstrated problem solving abilities and data interpretation skills
• Logical, strategic thinker
• Self-motivated and responsible, with a strong work ethic
• Demonstrated leader in the field with sustained performance and accomplishments. Ability and experience in turning around and remediating compliance challenges. Ability to plan and budget at a senior level.

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