Senior (Sr) Specialist, Change Control and Deviation Management

The Senior (Sr) Specialist, Change Control and Deviation Management role will be involved in implementation and maintenance of Change Control and Deviation Management procedures at our Company’s Wilmington Biotech. The Sr Specialist will ensure the processes conform to our Company’s policies and comply with Current Good Manufacturing Practices (CGMPs), Health Agency regulations, and all other applicable governing regulations, with the mission and ambition to manufacture breakthrough medicines for patients around the world.

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Close collaboration with high-performance talent from our Company’s global team, the site team, and the biotechnology industry to develop and execute these Quality Management Systems and processes will be key. The successful candidate will be an individual and team member who supports building the future of our Company’s antibody drug conjugates and high potent compounds through a Quality culture that delivers unconstrained supply, that is ‘Right First Time’, to patients worldwide.

As necessary and when applicable, providing training and guidance on the interpretation and implementation of our Company’s policies and regulatory requirements will also be key priorities for the Sr Specialist. Throughout development of the new Wilmington Biotech facility, the successful candidate will focus on the deployment and maintenance of Change Control and Deviation Management processes., With energy and enthusiasm, the Change Control and Deviation Management Sr Specialist will:

• Establish and maintain robust systems for Change Control and Deviation Management, in alignment with the our Manufacturing Division Quality Management System (QMS), for the Wilmington Biotech site
• Manage and monitor the processes for the site, including but not limited to, providing guidance and support to Change/Deviation Owners, review the Change Management System dashboard, escalate Changes/Deviations with potential risk(s) accordingly, track and trend Deviations
• Serve as site Subject Matter Expert (SME) for the deviation management and change control system.
• Will monitor performance of the site change control and deviation management system, providing structure for performance monitoring across the site teams.
• Support compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements for Change Control and Deviation Management
• Provide Change Control and Deviation Management information necessary for the Annual Product Quality Review (APQR), as applicable and appropriate
• Responsible for provision of Change Control and Deviation Management metrics in relation to the Quality Council process
• Advocate continuous improvement in the Change Control and Deviation Management systems
• Serve as site topic lead for deviation management and change control and provide training to end users
• Take part in the Change Control and Deviation Management communities of practice/knowledge networks
• Support external CGMP audits (e.g., Regulatory Authorities, Global Quality) as SME in Change Control and Deviation Management
• Knowledge of US and European GMP guidelines, ICH, and other international regulatory requirements, as applicable to the site

REPORTING STRUCTURE

This position will report into the Site Quality Management Systems (QMS) Lead., Coaching Research Curiosity Marketing Annuities Operations Leadership Management Innovation Wholesaling Fundraising AI Adoption Market Trend Communication Presentations Accountability Prioritization Tax Accounting Business Acumen Social Security Customer Service Virtual Training Digital Marketing Influencing Skills Business Valuation Strategic Thinking Business Decisions Customer Engagement Business Priorities Emerging Technologies Operational Data Store Artificial Intelligence Employment Applications Strategic Prioritization Verbal Communication Skills Voice of the Customer (VoC) Employee Assistance Programs Health And Wellness Coaching Influencing Without Authority Continuous Improvement Process Customer Experience Improvement Customer Experience Strategy (CX) +0 Consultant, AI Portfolio Mgmt Lincoln Financial

Radnor, PA*On-Site

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Wilmington, DE*On-Site

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Auditing Dashboard Chemistry Operations Enthusiasm Innovation Compassion Adaptability Microbiology Self-Starter Communication Biotechnology Change Control Pharmaceuticals Decision Making Quality Control Quality Culture Telephone Skills Change Management Quality Assurance Functional Skills Project Management Influencing Skills Quality Management Results Orientation Contingent Workforce Deviation Management Regulatory Compliance Product Quality (QA/QC) Automation Systems Design Quality Management Systems Balancing (Ledger/Billing) Good Manufacturing Practices Continuous Improvement Process Current Good Manufacturing Practices (cGMPS), This role requires a seasoned individual with a minimum of 5 years’ experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.

A self-starter and results-focused, the successful candidate will have contemporary knowledge of relevant CGMPs, regulations, and current industry trends.

Technical

• Must have at least 1 year of operational experience
• Must have experience in Change Control and Deviation Management

People

• Demonstrated knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirements
• Knowledgeable in Industry Best Practices for quality and compliance related topics
• Strong collaboration and cross-functional skills to support continuous improvement, promote knowledge sharing, and implement best practices across the site and Compliance functions on global and local levels
• Strong verbal and written communication skills, as well as project management skills
• Demonstrated ability to influence areas not under direct control to maintain compliance with the requirements of the Change Control and Deviation Management systems
• Demonstrated ability to make and act on decisions while balancing speed, quality, and risk

Education

• Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering, or equivalent.
• Direct experience in manufacture of antibody drug conjugates and/or sterile manufacturing preferred.

Required Skills: Adaptability, Antibody Drug Conjugates (ADC), cGMP Regulations, Change Management, Decision Making, Deviation Management, GMP Compliance, Good Manufacturing Practices (GMP), Performance Monitoring, Pharmaceutical Quality Assurance, Product Disposition, Project Management, Quality Assurance Processes, Quality Management, Quality Management System Improvement, Quality Standards, Regulatory Compliance, Self Motivation

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is $106,200.00 - $167,200.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.