Head of Global Disposition, Global Development Quality
West Point, PA, USA | Merck
Industry:Pharmaceutical / Biotech
Job Description:48 people have viewed this job
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 planning activities.Provide updated information as needed for Estimated Actuals and LROP reports.
Remain informed of current GMP requirements and industry trends as described in applicable worldwide regulations and industry standards.Provide comments on proposed regulations and communicate impacts to client areas.Maintain an expert level of knowledge related to specialized area of technical expertise.
Manage the auditing and approval of production and analytical documentation accompanying the release, recall, or re-evaluation dating for clinical supply materials to ensure conformance to appropriate worldwide regulatory requirements.Provide guidance to each department on GMP issues identified during the production of clinical supplies, including those at contractors or licensees.Evaluate deficiencies and assess impact on compliance status.Notify appropriate Quality and support area management of compliance issues and performance trends.
Coordinate preparations and serve as primary contact for regulatory agency inspections.Accompany regulatory agency officials, conducting inspections of facilities or operations in supported areas, including Pre-Approval, GMP or Drug Enforcement Administration inspections and issue formal reports of inspection activities.Facilitate inspections by corporate auditors or external, non-government auditors in supported areas.Coordinate the drafting of responses to inspectional observations to satisfy Merck and/or regulatory agency requirements.
Advise supported areas on the GMP compliance aspects of the design 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 material potentially available for use in clinical through the establishment of license-agreements and advises senior staff on recommendations.Works with licensee on the identification of information required for Merck reviews of such programs.
Facilitate resolution of inter-disciplinary GMP issues in all stages of product and process development.
Coordinate the development of GMP policies or procedures impacting multiple supported departments.Ensure that all GMP SOPs in supported areas are consistent with established policies and current applicable regulations.
Manage the audit and/or approval of GMP documentation for applicable regulatory filings, clinical supply, development and technology transfer, computerized systems, facility and/or equipment qualification.Ensure compliance with regulatory and Merck requirements.Evaluate deficiencies and assess impact on compliance status.
Oversight of the development and approval of validation/qualification standards, strategies, policies and procedures with regard to GMP requirements, for processes, equipment, facilities and/or computerized systems.
Manage and develop staff by ensuring that objectives are set, monitoring ongoing work performance, providing constructive feedback, conducting performance reviews and employee development discussions.
Specific and/or additional duties may include, but are not restricted 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 on new regulations and guidelines dealing with validation.
Coordinate inquiry and complaint investigations from clinical investigations or regulatory agencies.
Responsible for ensuring the appropriate validation or qualification of all new facilities and renovations
Required: B.S., M.S. and/or PhD. Degree in an appropriate Science or Engineering discipline.
Minimum of ten (10) years with B.S. /M.S. or eight (8) years with PhD of pharmaceutical, biological vaccine, or chemical industry, or government drug regulatory agency experience, with three (3) years in a quality or compliance role and five (5) years in a managerial position.
Extensive working knowledge of cGMP regulations.
Broad understanding and technical competence covering the activities of supported areas.
Effective communication, supervisory, negotiation, problem-solving and interpersonal skills with demonstrated project management abilities is necessary to perform job responsibilities.
Demonstrated ability to organize and communicate technical information, and understand and interpret international regulations influencing supported areas.
Experience in leading a quality assurance organization in a complex biopharmaceutical environment
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