Senior Specialist, Quality
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.
The position resides in the WP Quality Assurance group. The primary roles and responsibilities may include:
- Authoring and Reviewing Annual Product Reviews (APRs)
- Authoring and managing Quality Agreements (QAs) concerning both other Merck Sites and external vendors and/or contractors involved in the GMP aspects of the Site
- Provide Quality oversight of supplier information across all categories of suppliers that service WP. Provide quality input for assessing risk associated with use of specific suppliers, audit results, etc.
- Manage Supplier Management system by processing / approving changes and auditing system data as appropriate.
- Serve as Quality subsystem owner / subject matter expert for relevant Quality system(s).
- Coordinating BPDR/FAR activities, including oversight of the BPDR meeting.
- Coordinating Fact Finding, Recall Committee, and Market Action activities
- Performing and coordinating Product Quality Complaint/Adverse Event activities including PQC intake, handling sample returns, investigations, and compilation and analysis of PQC and AE data
- Working within the Change Control System to ensure requirements are met. Running IPT Advisory Council meetings.
- Performing review and approval of automation changes.
- Providing Quality oversight for Deviation Management Program.
- Performing review and approval of deviations.
- Providing Quality Leadership and oversight for risk management across the Site
- Performing internal audits.
- Participating in regulatory inspections, including facilitating and RMT activities
- Presenting system overviews to regulators as needed.
The Quality Assurance Center of Excellence is the 'Voice of Quality' for the Site and is responsible for providing Quality direction and oversight to the WP Site in the management of those areas assigned, such as Annual Product Reviews, Supplier Management, Market Actions and Regulatory Communications, Product Quality Complaints, Internal Auditing, Training, Annual Product Review, Supplier Management, Change Control, Inspection Management, Documentation, Manufacturing Batch Records, MES, Quality Planning, general End to End support and Risk Management in order to maintain compliance with Regulatory requirements. The individual has a key role in the execution and deployment of WP Site and MMD priorities. The Senior Quality Specialist ensures alignment across the site in the execution of their assigned areas. The individual is responsible for the maintenance of Quality Systems at the West Point site in accordance with cGMPs and international regulations, Merck guidelines, procedures, and policies. In addition, the individual is expected to identify and implement continuous improvement activities in their assigned area.
The Senior Quality Specialist may participate in or lead key compliance projects at the site aimed at elevating our compliance posture. Project Managers are expected to fully manage all aspects of assigned projects, including but not limited to: quality decision-making, stakeholder management, issues identification and resolution, and drive all aspects of project in alignment with established timelines.
- Author, review, and approve Annual Product Reviews / Product Quality Reviews for all of the products that West Point manufactures
- Providing Quality oversight of supplier information across all categories of suppliers that service West Point. Function as site administrator for Supplier Management system and serving to maintain accurate information for West Point’s supply chains.
- Confirming vendor supply chains (as applicable) and evaluating risks for supply chains based on Merck requirements.
- Authoring and managing Quality Agreements (QAs) concerning internal Merck Sites and external vendors and/or contractors involved in the GMP aspects of the Site.
- Support ad-hoc data requests and analysis
- Lead and facilitate compliance projects to support sustaining and/or enhancing compliance
- Lead and facilitate MPS projects to support enhanced efficiency and effectiveness
- Author, review, and approve procedures and other control documents.
- Author, review, and approve quality agreement with both internal and external partners
- Present/discuss GMP deliverables as the SME with Domestic and International Regulatory Agency inspectors and auditors
- Assist with aspects of Regulatory Inspections and commitments
- Participate in internal audits and shop floor inspections
- Execute market actions, Regulatory Agency Communications (FARs, BPDRs)
- Performing and coordinating Product Quality Complaint/Adverse Event activities
- Process Change Management
- CAPA Management
- Automation Compliance
- Performing gap analysis and remediation
- Quality Support/ownership for applicable automation systems
- Regulatory surveillance
- Conduct training on compliance topics
- Execute projects as required by the Associate Director
Assurance organization, including:
- SOP and Batch Record Management
- Process Change Management
- CAPA Management
- Audits and Inspections
- Automation Compliance
- Deviation Management
- Inspection Management, QMS / Quality Council Management
- Quality Risk Management
- Complaints, Market Actions, Data Auditing
- B.S. degree in scientific or engineering field or a minimum of 5 years relevant Quality work experience
- Minimum 5 years in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality decision making responsibility
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment.
- Demonstrated self-starter with capability to develop innovative solutions to challenges.
- Deliver results across diverse areas at Site
- Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.
- Speaks with courage and candor.
- Strong written and verbal communication skills.
- In-depth working knowledge and application of GMPs.
- Proven ability to manage multiple projects simultaneously.
- Strong analysis and critical thinking skills are required for this position
- Ability to function effectively with ambiguity, changing priorities, and aggressive deadlines.
- Ability to make risk-based decisions
- Excellent technical writing skills are required along with strong editing skills
- Experience with SAP and Trackwise
- Supplier collaboration/relationship, and influencing skills
- Ability to drive results and influence others in the areas of data requirements, Regulatory/compliance issues, and timelines
- Project management and facilitation skills required to drive projects to completion
- Strong business process analysis skills for areas/processes for streamlining, and process re-engineering to enhance value proposition of function.
- Ability to work as part of a high performing team: good collaboration skills, high level of emotional intelligence, ability to maintain objective viewpoints
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: Qual Assurance & Ops Generic
Employee Status: Regular
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Company Trade Name: Merck