Senior Specialist, Quality Systems & Compliance, Deviation Management
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Reporting to the Director Quality Systems & Compliance, the Senior Specialist Quality Systems & Compliance will provide focus, governance, guidance, and continuous improvement to the global Deviation Management and Corrective and Preventive Action (CAPA) programs. The incumbent(s) will join a team responsible for instituting standard practices across the internal and external global manufacturing network in the disciplines of Deviation Management and CAPA as part of the Quality Systems Improvement Program (QSIP).
The successful candidate(s) will help build and improve the global management programs by defining requirements established via in depth review of existing systems, in concert with strategic direction facilitated by the global business model and regulatory compliance. The incumbent(s) will be responsible for the generation of metrics to monitor the health of the redesigned quality systems. The person(s) will help individual sites or functional areas carry out a gap analysis for the new Quality manual topics versus the current chapter deployment to evaluate and document gaps and identify corrective actions. The successful candidate(s) will also participate in Change Execution Management activities to facilitate deployment of the standardized Deviation/CAPA systems.
Primary activities include, but are not limited to:
- Help to standardize current global deviation management / CAPA quality systems in the Quality Manual.
- Help global sites and functions build appropriate gap closure plans to deploy the standardized deviation management / CAPA systems.
- Develop and deliver training for standardized deviation management / CAPA systems and support Hyper Care for global sites, external network, and functional areas after systems go live.
- Interface with IT and other work streams to define system requirements and ensure robust interdependencies; participate in IT User Acceptance Testing and development of guidance documents for use of the global IT system in execution of Deviations and CAPAs.
- Support Change Execution Management activities.
- Serve as a Deviation Management / CAPA Subject Matter Expert (SME) for the global network ensuring compliance with all global and regulatory standards; provide direction and implement best practices and standards.
- Monitors Sub-system health and proactively identifies, investigates and resolves trends and patterns before they impact compliance and supply. Supports development and execution of significant innovative projects that drive operational improvements within the Sub-system.
- Maintains and partners with an integrated end-to-end network of site and functional area Deviation Management SME’s and participates in a Community of Practice or Knowledge Network to foster knowledge sharing, drive consistent compliant application of Sub-system requirements, and improve personnel capabilities.
- Provides technical guidance to sites or functional areas on issues related to the Sub-system and uses expertise to develop global remedial actions including execution of appropriate changes that impact global policies, procedures and guidelines.
- Assists sites and functional areas with investigations and troubleshooting.
- Evaluates and analyzes new and revised regulatory guidance / policies and regulatory intelligence and translates requirements into internal quality practices and standards.
- Applies Lean Six Sigma methodologies and risk management principles to proactively anticipate quality risks, identify and implement mitigation plans and improvement opportunities.
- BS in a relevant field of Science or Engineering.
- Minimum of Five (5) years experience in Pharmaceutical industry and or Root Cause Analysis / Problem Solving.
- Understanding of FDA / International regulations and cGMPs with experience in deviation management, CAPAs, compliance issues, and industry quality assurance practices and systems.
- Experience using SAP, Trackwise, or comparable IT system.
- Strong communication and technical writing skills.
- Must possess working knowledge of Microsoft Office Suite.
- Current or previous change execution management experience for significant organizational or system changes.
- Lean Six Sigma methodologies.
- Working knowledge in Quality Risk Management Tools and principles.
- Demonstrated Technical and / or Manufacturing experience.
- Demonstrated innovative mindset.
- Ability to influence others without authority.
- Experience training others.
- Ability to interpret complex business and / or technical documents, write comprehensive reports, detailed business correspondence, and the ability to present to groups across the organization as needed.
- Works independently with all levels of the organization, and has demonstrated the following skills: Rapid / Disciplined decisions, Acts with courage and candor, Drives results, Escalation of issues / concerns to management, and ability to Prioritize, Align and Simplify.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Quality GMP Related
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck