Site Quality Manager – FinPack Div – Nypro Healthcare
Requisition Number: 221942
Work Location: Clinton, MA
About Our Company
Nypro Healthcare, a Jabil Inc. company, offers healthcare and pharmaceutical customers the widest array of design and manufacturing capabilities in the industry. With more than 40 years of experience, our highly specialized teams meet the complex and regulated demands of the diagnostics, medical devices and pharmaceutical markets enabling the world’s leading brands to fulfill their market potential. Nypro Healthcare’s customer focused services range from ideation to device development support, engineering, supply chain optimization, vertical plastics and electronics to device assembly operations, all at our purpose-built facilities that support stringent healthcare requirements and protect our customers’ intellectual property.
- Responsible for ensuring that all departments/divisions within a plant where devices are assembled/packaged with drug/biologic products or diagnostic reagents (Finished Product) comply with applicable regulations and cGMP practices of the US Food and Drug Administration, EU and other global competent authorities.
- Manages all activities and personnel (directly or indirectly) for handling Finished Product from receiving to shipping as well as assessing and ensuring compliance through training, auditing and corrective and preventive actions.
- Serves as the Management Representative for the site, as defined in the following Quality Management System standards & regulations:
- 21 CFR Part 820 Quality System Regulation
- ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes
- Manages the quality unit, executing all functions to fulfill quality assurance requirements to maintain regulatory compliance
- Position reports directly to the Director Quality – Nypro Clinton for all responsibilities and performance defined within.
Essential Duties & Responsibilities
- Liaisons with external parties on matters relating to the QMS.
- Ensuring that processes needed for the QMS are established, implemented and maintained.
- Reporting to senior management on the performance of the QMS and any need for improvement.
- Ensuring the promotion of awareness of Applicable Regulations and customer requirements throughout the organization.
- Responsible for maintaining compliance to 21 CFR Parts 210 and 211 and 21 CFR Part 820 as well as any other relevant global regulations pertaining to the product.
- Participates as a Program Management team member to ensure that Advanced Quality Planning is performed and customer and regulatory requirements are transferred into issued documentation for use in production.
- Ensures that suppliers and contractors are appropriately approved.
- Trains or manages training to ensure that personnel engaged in the receipt, manufacture, processing, packing and holding of Finished Product and their components have the education, training and experience to perform their assigned functions.
- Ensures that drugs, biologics, reagents and associated packaging materials as well as work-in-process (WIP) and Finished Product are stored in a secure location under conditions appropriate to the product.
- With the support of the plant management and the Healthcare (HC) FinPack team, ensures that the facility and equipment used for manufacture, testing and packaging of Finished Product is of the appropriate design, adequate size and location for the intended use and are cleaned and maintained to prevent contamination and mix-up.
- Ensures that the cleaning and environmental monitoring is appropriate to the product including cleaning validation, viables monitoring, pyrogen, bioburden or other required testing.
- Ensures that components, WIP, and Finished Product are inspected according to all requirements, batch records are reviewed and approved by Quality prior to release, and that, if errors have occurred, the errors have been fully investigated.
- Ensures that Quality reviews and approves all documents that impact the identity, strength, quality and purity of the Finished Product and that documentation is in compliance with HC GBU, plant, and relevant regulatory requirements.
- Participates in FDA audits and provides input to any 483 responses.
- Participates in FinPack customer audits and provides input to Nypro response to any findings.
- Audits or manages additional auditors to assess compliance to Finished Product, Nypro and regulatory requirements.
- Assists Quality Engineers, Engineering and Operations staff in developing quality plans, inspection work instructions and procedures, equipment operation documents and any other documents required for batch records.
- Reviews FinPack customer and supplier Quality Agreements.
- Ensures that all plant licenses and registrations are maintained and current.
- Participates in corrective action investigations associated with Finished Product and ensures that true root cause and effective corrective action is enacted.
- Assists in the resolution of FinPack customer complaints with the assistance of assigned quality, operations, and engineering personnel.
- Lead the Quality Assurance Department in operating with a high level of efficiency, integrity and enthusiasm, striving to achieve excellence in all endeavors.
- Recruit and maintain a high-caliber staff appropriate to business circumstances.
- Develops, motivates and challenges all team members to perform to their full potential, providing direct and timely feedback in formal and informal media.
- Evaluates and schedules appropriate training programs and/or seminar for the Quality Assurance staff, including direct employees.
- Delegates and organizes departmental workload according to project assignments.
- As a member of the site Management Team, be a creative and proactive contributor to bolster process & quality continuous improvement.
- Provides input to and support of plant and company safety initiatives.
- Co-ordinates interaction between the Quality Department and all other manufacturing and support functions.
- Monitors Quality Engineering and Supplier Engineering activities and their impact on the continuous improvement of process yields and efficiencies.
- Serve as an effective business partner
- Support Business Unit Managers / Directors, providing leadership and direction for quality initiatives and business strategic plans
- Provide representation for site quality function for Nypro Healthcare customers.
- Supports financial budgeting, TM1 resource allocation responsibilities and reporting for the responsible cost centers
- Establish and maintain effective measures for assuring product quality
- Oversees the effectiveness of up front quality planning for new products to ensure appropriate quality systems and processes required to support the introduction are developed and implemented.
- Manages statistical analysis projects to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Manages and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Monitor the product acceptance levels (yields) as seen by the customer and ensure that appropriate preventive measures are taken.
- Maintain plant Master Validation Plan (MVP), as needed, for product that will be used in an FDA regulated market. Ensure conformity of initial and ongoing validations performed in support of the GMP quality systems.
- Generate and maintain applicable quality system documentation, as needed. Documents such as Device Master Record (DMR), Design History File (DHF), validation protocols, for example, and other specified documents in support of customer projects.
- Serve as Management Representative for the site Quality Management System:
- Ensuring all processes needed for the quality management system are established implemented and maintained, including validation, document control, audit.
- Promote the Quality Policy and enable a quality culture to ensuring awareness of customer requirements throughout the organization.
- Reporting to top management on the performance of the quality management system and any need for improvement through periodic Management Review
- Act as liaison with external parties on matters relating to the QMS.
Other responsibilities may be assigned from time to time as directed by Nypro Healthcare Leadership, based on company needs.
Education & Experience Requirements
- Bachelor’s or Master’s Degree in Biological Science, Biomedical, Chemistry, Engineering, Clinical or equivalent
- 7+ years of relevant experience in Quality Assurance / Quality Control within drug, medical device, IVDD or related industries, with at least 3 years of relevant experience in medical device or pharmaceutical industry experience.
- Experience in the following FDA regulations and ISO requirements:
- 21 CFR Part 820 Quality System Regulation
- Applicable sections of 21 CFR Part 210/211 Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs (Part 2010); and Current Good Manufacturing Practice For Finished Pharmaceuticals (Part 211),
- 21 CFR Part 4 Regulation of Combination Products
- Where applicable, ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes
- Professional certifications preferred, such as CQM/OE, CQE, CQA, CSSBB, PMP
- Excellent verbal and written communications skills
- Effective interpersonal and problem solving skills with a demonstrated ability to interact with individuals from internal, external (clients) and third party vendors
- Established track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization
- 3+ years of Program Team participation with a demonstrated progression of complexity of assignment and independence.
- Some overnight travel may be required
Jabil is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other status protected by law.