Sr. Product Quality Assurance #JN -062021-65439
Branchburg, New Jersey
Posted on: June 11, 2021
Industry: QA Testers
Job Number: JN -062021-65439
- Responsible for the identification and remediation of potential Quality and Compliance gaps and improvement opportunities of assigned products with respect to compliance to local and global policies/procedures and external regulatory requirements worldwide. Products include medical devices, raw materials, processing components/solutions and HCT/P’s produced by AbbVie Branchburg site and/or third-party manufacturers.
- Ensures business objectives are met with regards to quality, compliance and continuous improvement related to the assigned products. Acts as the primary quality representative for the global product gap remediation activities and build and maintain relationships with key Operations groups including Internal & External Manufacturing, Science & Technology, External QA, Commercial and Global Supply Chain. In addition, works closely with Regulatory Affairs and R&D, as appropriate, to ensure alignment on strategic improvements on product quality.
- Leads the collection of data to develop a clear picture of overall quality and compliance state for the associated products. Identifies potential quality and compliance gaps and improvement opportunities. Develops Product Quality Assurance remediation strategy based on the assessment and implements the agreed strategy to further improve the quality and compliance status of the products.
- Provides Quality Governance and provides support to the Corporate Product Performance Team (PPT) as appropriate, including issue management and change management. Supports Regulatory to prepare submissions associated with product remediations.
- Interfaces with site Quality professionals for the remediation activities and directs cross-functional team members to achieve on-time quality deliverables. Ensures delivery of all quality elements needed to facilitate closure of the identified quality and compliance gaps and improvement opportunities.
- Makes key decisions on product quality, compliance and regulatory conformance issues and elevates medium and high-risk gaps to Site Head of Quality.
- Develops and writes necessary quality and technical documentation to ensure that the appropriate quality, compliance and regulatory aspects are met for the products and quality and compliance gaps and improvement opportunities identified in the remediation plan are resolved.
- Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled.
- Establishes and maintains relationships and open communication with key stakeholders on the progress of the remediation activities and provide guidance on quality issues or events related to the products as needed.
- Leads and supports the resolution of the product related CAPA actions and the closure of the CAPAs.
- Prioritizes programs, initiatives, and problem solving with consideration for impact to site timelines, resources, and conflicting priorities.
- Responsible for the strategic leadership of Risk Management for the assigned products. Develops and implements a strategy for all remediation and improvement activities related to the products. Influences the decision-making process to ensure quality requirements are included when improvement initiatives take place.
- Ensures that the products remain in full compliance with worldwide regulatory requirements during all remediation activities.
- Masters’ Degree in relevant Life Science or other technical required. Technical or Analytical background is required for problem resolution with technical, quality, product and or engineering related issues.
- Minimum of 6+ in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in pharmaceutical or medical device industries. Direct Plant experience in a pharmaceutical or medical device industry setting with a minimum of 3 years preferred.
- Regulatory inspection experience with direct interaction with regulatory inspectors.
- Comprehensive knowledge and understanding of Medical Device, HCT/Ps and/or pharmaceutical regulations and technologies (sterile, biological, devices, Clean room).
- Possesses knowledge and a skillset to operate within an environment that requires a high degree of urgency, strong analytical and problem-solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leader, team member and individual contributor.
- Strong quality assurance / control, manufacturing, laboratory, design control, risk management, technical support, regulatory, and / or validation background is required.
- A wide range of activities are undertaken from long term strategy development to short term crisis management. The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, regional, and local objectives to effectively manage the action plans that will resolve the issues.
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