Senior Specialist, Quality Assurance - Hybrid

Job Description

Our team within our Research & Development Division's Quality Assurance, Global Development Quality organization is responsible for oversight of manufacturing activities for the Clinical Supply Chain. Partnering across our internal facilities and external contract manufacturers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. We are looking for strong leaders with an international and cross-functional mindset, strong interpersonal skills, the ability to maintain and develop strong working relationships with network leaders and progress our systems and process development to the next level.

The Sr. Specialist, Clinical Supplies Quality Operations & Technology, plays a critical role supporting the enabling functions within Quality for Medical Device and Combination Product (MDCP) assembly and packaging operations in the Clinical Supply Chain. This includes execution of program strategies, improvement initiatives, ensuring operational readiness / risk mitigation for clinical MDCP operations in support of current and future MDCP pipeline. The position collaborates closely with the key stakeholder groups including Global Clinical Supplies, Global Quality, Global Regulatory Affairs, Global Clinical Trial Operations, Device Development and our Research & Development Division's IT team as well as multiple Quality Assurance sites and functions within the clinical supply chain.

Primary Responsibilities:

• Maintain in-depth technical / quality expertise on MDCPs and GMP requirements in support of program specific Device / Analytical Working groups and relevant impact on the Clinical Supply Chain.

• Represent Device Quality Operations & Technology to bring awareness and alignment to Cross- functional Quality support teams across the stages of manufacture for both internal and external combination product programs.  

• Independently support / approve documentation required to support Clinical Operational Readiness for MDCPs inclusive of SOPs, Change Management, Deviation investigations, Analytical Method and Specification approval

• Participate in Device Specific Risk Management activities for clinical readiness.

• Identify need for / and or develop SOPs to ensure effective and robust Quality systems and processes are in place for Clinical MDCPs.

Education Minimum Requirements: 

• Bachelor’s degree in a science, engineering, or related discipline; an advanced degree or certification in a management, technical, quality, or regulatory discipline will be preferred.

Required Experience Knowledge and Skills:

• A minimum of 5 years of relevant experience working within the pharmaceutical industry or advanced Degree with 3 years relevant experience

• Strong comprehension of regulatory agency regulations and requirements coupled with proficiency in interpreting and applying current Good Manufacturing Practices (cGMPs) to our Research & Development environment.

• Direct experience in GMP quality, operations, or laboratories. GMP experience at the interface between quality and either an internal manufacturing or laboratory function or external contract manufacturing, laboratory, or related operations.

• Demonstrated ability to manage projects and priorities, to meet deliverables and timelines.

• Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills.

Preferred Experience and Skills:

• Understanding and experience in Research & Development activities specifically related to clinical supplies, Medical Device/Combination Products, and implementation of new technology, coupled with the ability to interact with and influence stakeholder subject matter experts on various initiative and issues.

• Demonstrated knowledge of continuous improvement and project management methodologies; ability to lead matrix teams and support complex cross-functional initiatives, recognize improvement opportunities, develop appropriate solutions and follow through on implementation.

• Demonstrated excellence of skill in communicating (oral and written) effectively with diverse individuals/ groups at all levels.

• Demonstrated experience in quality risk management in the pharmaceutical industry.

• Computer skills; knowledge and competency in electronic inventory systems, quality management systems, PowerPoint, Excel and Word.

Current Employees apply