Merck Head of Global Disposition, Global Development Quality in West Point, Pennsylvania
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 is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The Executive Director is responsible for the management, execution and leadership of Due Diligence activities and Small Molecule/Biologics/Vaccines Drug Substance and Drug Product Development Quality activities to ensure compliance with current Good Manufacturing Practices (cGMPs), applicable worldwide regulations and Merck requirements for supported area(s). Additional responsibilities include providing assessments to senior management as to the compliance status and risk posture of supported area(s), and for the direction of policies and procedures in alignment with current regulatory expectations as well as supporting the development of capacity planning and annual Profit Plans and ensuring department financial goals are met.
Responsibilities include, but are not limited to, the following:
Provide information for inclusion in annual profit planningactivities.Provide updated informationas needed for Estimated Actuals and LROP reports.
Remain informed of current GMP requirements and industry trendsas described in applicable worldwide regulations and industry standards.Provide comments on proposed regulations andcommunicate impacts to client areas.Maintain an expert level of knowledge related to specialized area oftechnical expertise.
Manage the auditing and approval of production andanalytical documentation accompanying the release, recall, or re-evaluationdating for clinical supply materials to ensure conformance to appropriateworldwide regulatory requirements.Provide guidance to each department on GMP issues identified during theproduction of clinical supplies, including those at contractors orlicensees.Evaluate deficiencies andassess impact on compliance status.Notify appropriate Quality and support area management of complianceissues and performance trends.
Coordinate preparations and serve as primary contact forregulatory agency inspections.Accompanyregulatory agency officials, conducting inspections of facilities or operationsin supported areas, including Pre-Approval, GMP or Drug EnforcementAdministration inspections and issue formal reports of inspectionactivities.Facilitate inspections bycorporate auditors or external, non-government auditors in supported areas.Coordinate the drafting of responses to inspectionalobservations to satisfy Merck and/or regulatory agency requirements.
Advise supported areas on the GMP compliance aspects of thedesign of facilities, selection of equipment (including computerized systems),preparation of departmental standard operating procedures, quality practices,policies, and interpretation of applicable worldwide regulations.
Assessment of the suitability of GMP data and materialpotentially available for use in clinical through the establishment oflicense-agreements and advises senior staff on recommendations.Works with licensee on the identification ofinformation required for Merck reviews of such programs.
Facilitate resolution of inter-disciplinary GMP issues inall stages of product and process development.
Coordinate the development of GMP policies or proceduresimpacting multiple supported departments.Ensure that all GMP SOPs in supported areas are consistent withestablished policies and current applicable regulations.
Manage the audit and/or approval of GMP documentation forapplicable regulatory filings, clinical supply, development and technologytransfer, computerized systems, facility and/or equipment qualification.Ensure compliance with regulatory and Merckrequirements.Evaluate deficiencies andassess impact on compliance status.
Oversight of the development and approval ofvalidation/qualification standards, strategies, policies and procedures withregard to GMP requirements, for processes, equipment, facilities and/orcomputerized systems.
Manage and develop staff by ensuring that objectives areset, monitoring ongoing work performance, providing constructive feedback,conducting performance reviews and employee development discussions.
Specific and/or additional duties may include, but are notrestricted to:
Develop policies for sterile and non-sterile validation,revalidation and process change control in supported areas. Review and approve validation protocols. Interpret and provide direction to staff onnew regulations and guidelines dealing with validation.
Coordinate inquiry and complaint investigations fromclinical investigations or regulatory agencies.
Responsible for ensuring the appropriate validation orqualification of all new facilities and renovations
- Required: B.S., M.S. and/or PhD. Degree in an appropriateScience or Engineering discipline.
Minimum of ten (10) years with B.S. /M.S. or eight (8) yearswith PhD of pharmaceutical, biological vaccine, or chemical industry, orgovernment drug regulatory agency experience, with three (3) years in a qualityor compliance role and five (5) years in a managerial position.
Extensive working knowledge of cGMP regulations.
Broad understanding and technical competence covering theactivities of supported areas.
Effective communication, supervisory, negotiation,problem-solving and interpersonal skills with demonstrated project managementabilities is necessary to perform job responsibilities.
Demonstrated ability to organize and communicate technicalinformation, and understand and interpret international regulations influencingsupported areas.
- Experience in leading a quality assurance organization in a complexbiopharmaceutical environment
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 Clinical, Non Clinical Quality Assurance
Other Locations: NA-US-NJ-Rahway
Title: Head of Global Disposition, Global Development Quality
Primary Location: NA-US-PA-West Point
Requisition ID: CLI008731
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