Senior Specialist, Quality Assurance - Hybrid

MSD; Rahway (NJ); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Specialist in Clinical Supplies Quality Operations & Technology. This pivotal role involves overseeing quality assurance for Medical Device and Combination Product operations within the Clinical Supply Chain. The ideal candidate will leverage their extensive knowledge of regulatory requirements and Good Manufacturing Practices to ensure compliance and operational readiness. Collaborating with various stakeholders, you will drive improvement initiatives and manage quality systems to enhance clinical operations. Join a forward-thinking organization committed to delivering high-quality products to patients worldwide.

Qualifications

• 5+ years of experience in the pharmaceutical industry or 3 years with an advanced degree.
• Strong knowledge of cGMP and regulatory compliance.

Responsibilities

• Maintain technical expertise on MDCPs and GMP requirements.
• Support documentation for Clinical Operational Readiness.

Skills

Regulatory Agency Regulations

Good Manufacturing Practices (cGMP)

Project Management

Cross-Functional Teamwork

Communication Skills

Education

Bachelor’s degree in Science or Engineering

Advanced degree or certification in management or quality

Tools

Electronic Inventory Systems

Quality Management Systems

Microsoft PowerPoint

Microsoft Excel

Microsoft Word

Job description

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 delivering 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.

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Hybrid

Shift: 1st - Day

Job Posting End Date: 03/27/2025