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Job Description: The Device Quality Lead, Combination Products is responsible for ensuring the compliance of combination product/devices to relevant HA regulations, and for reviewing and approving design control and risk management documents. This position represents Global Biologics Quality on combination product design and development projects and is responsible to (i) establish, maintain and improve Quality System documents governing combination product life cycle management for both device constituent and secondary packaging; (ii) review design control deliverables and ensure that appropriate design control processes are implemented in collaboration with R&D Quality, and (iii) ensure that appropriate integrated quality risk management principles are incorporated, executed, and documented throughout the life cycle of the product. Additionally, the position will provide subject matter expertise during the audit of device component suppliers, external design houses, service providers, contract manufacturers, and provide support to the Associate Director, Packaging and Logistics Quality as necessary for combination product packaging development and lifecycle management.
This is intended to be a general job description and should not be construed as all inclusive.
MAJOR DUTIES AND RESPONSIBILITIES State the most important activities and accountabilities of this position. Describe how these activities and accountabilities can influence the achievement of company or business goals.
The Device Quality Lead, Combination Products has job responsibilities that include but are not limited to:
• Provide above-site quality oversight and support to MS&T, Global Procurement and GPT.
• Ensure compliance to CGMP, 21 CFR Part 4, and company standards.
• Conduct periodic audits of device component suppliers, external design houses, service providers, and contract manufacturers and distribution centers
• Author or coordinate the writing of comprehensive quality system documents. Initiate, update, review, or assist in the drafting of the quality manual, policies, directives, standard operating procedures and work instructions.
• Ensure that new medical device/drug combination products follow the appropriate design control process consistent with health authority regulations/expectations.
• Ensure risk management is executed through Risk Management Plans, Risk Files, Hazard analyses, and risk analyses eg dFMEA, pFMEA, uFMEA etc. throughout the life cycle of the product.
• Work closely with MS&T and GPT teams and provide quality oversight for upcoming design and process changes.
• Participate in Design Reviews for new product development. Ensure all actions that come out of Design Reviews are tracked and completed.
• Participate in teams to generate, update, or assist in the drafting of policies, procedures, and work instructions related to product quality metrics (eg, risk assessment for product quality complaints, product quality complaint surveillance thresholds).
• Provide internal or external training, as needed.
• Review and approve change control proposals, deviations, investigations, and corrective action/preventive action reports as part of quality support.
• Serve as SME for evaluating the impact and applicability of new device/combination product regulations via the ReACT process.
KNOWLEDGE / SKILL Describe the type and extent to which knowledge of a specific type is required to perform this job in a satisfactory manner. Where skills can be obtained through formal training / education and experience. List the type and amount of education and experience that would typically prepare an individual for this position.
• The position requires a minimum of a Bachelor of Science degree in Engineering, Pharmacy, Chemistry, Biology, etc..
Experience / Knowledge Desired:
• Experience in supporting the development and commercialization of medical device/drug or biologic combination products from a quality perspective is essential.
• Minimum of 5 years experience in medical device/drug combination product development and manufacturing role, in a Quality, Technical, or Regulatory position or a combination thereof.
• Experience with tech transfer of a device/combination product to a third Party manufacturer is preferred.
• Experience with 21 CFR 820.20, 21 CFR 820.50 and 21 CFR 820.100 highly desired.
• Expert in 21 CFR Part 4.
• Demonstrated experience leading and contributing through influence and working in cross functional teams to investigate and manage quality and compliance related issues.
• Demonstrated ability to make and act on decisions while balancing speed, quality, and risk.
• Demonstrated ability to work independently and with groups of people/teams in a complex changing environment.
• Excellent oral and written communication skills.
• Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
• Ability to provide innovative, compliant ideas or alternatives that create value including seeking new information and external insights.
• Pragmatic in approach with demonstrated ability to make sound, risk-based decisions
• A minimum of 2 years of CGMP/QSR auditing experience, preferably certified device auditor (e.g., ISO RAB, etc).
• In depth knowledge of product attributes as they relate to regulations..
• Ability to analyze and solve complex problems.
• Ability to work independently and use initiative.
• Ability to prioritize work and rapidly change priorities when necessary.
• Ability to develop win/win solutions.
Additional Job Requirements:
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Axelon Services, Corp is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity, national origin, disability, or protected veteran status.