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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Description:
The position is primarily responsible for executing and leading internal and external GMP audits following Merck's auditing policy and guidance to ensure compliance with worldwide regulatory expectations. This includes ensuring that facilities and buildings, equipment, personnel, organization, methods, procedures, records, reports, and/or controls are in conformance with Merck requirements and applicable global regulations.
Responsible to achieve and maintain qualification / certification status through robust training and continuing education programs to enable conducting audits of Human Health, Animal Health and Consumer Care Merck Sites, Contracted facilities, Distribution Centers, Business Partners and Suppliers. Responsible for accepting audit assignments, performing audit pre-work, conducting audits and ensuring post audit activities are completed within defined timeframes.
The position requires negotiating with external firms to attain acceptable corrective actions and independent generation of extensive, high quality, GMP documentation as well as extensive communication and partnership with divisional oversight groups and commercial sites.
Conducts projects as required to maintain and transform the effectiveness and efficiency of the auditing program, and ensure the audit program meets using site, management and regulator expectations. Provides support as an SME in various areas of regulatory requirements. Responsibilities
Qualifications: Education Minimum Requirement:
- Schedule and perform assigned audits and ensure timelines for audit steps (prework, conducting audit, issuance of audit report, CAPA receipt) meet established expectations. This requires approximately 50% worldwide travel.
- Review and approve audit reports.
- Maintain a broad based expertise of cGMP's, Merck Policies, Procedures and Guidelines, regulatory requirements, etc. that are pertinent to the pharmaceutical industry including, but not limited to Biologics, Medical Devices, Vaccines, Small Molecules, Combination Products, APIs and Controlled Substances.
- Obtain and maintain cutting-edge knowledge, application, and certification status for various technical/Quality auditing topics
- Serve as "Subject Matter Expert" in auditing and for stakeholders; generate and deliver cutting-edge training for a diverse audience
- Maintain awareness of evolving industry and regulatory trends/regulations. Assure that the Merck Audit Guidelines and audit training documentation are consistent with current worldwide regulatory expectations and are updated, as appropriate.
- Lead/support and develop novel approaches/innovative tools for observation trending/site risk profile generation as input to Sr. Management Quality Council
- Provide subject matter expertise to relevant Quality Manual chapters related to auditing and inspections, and ensures chapter documentation is consistent with current regulatory expectations.
- Support New Business opportunities through Due Diligence (electronic due diligence as well as on-site visits) and Pre-Contract Audits, issuance of reports, and evaluation of corrective and preventive actions.
- Function as Quality Lead in Sr. Management forum.
- Assist with preparation of annual audit schedule, using risk based approaches for auditor assignment
- Lead & Coordinate with Procurement and impacted Site Quality leads on critical audit findings and or audit refusals. Generate comprehensive presentations/summary of issues for effective communication to all levels, ensuring required assessments are performed.
- Provide regulatory inspection support to Merck Sites as it relates to the Divisional Audit program, status of audits, and specific audit results.
- Provides support and administrative functions for the electronic Supplier Tracking and Repository System, and assists in data maintenance.
- Leads initiatives / drive results in various projects, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet using site, management and regulatory expectations.
- Mentor new auditors to ensure comprehensive training and full understanding of auditor roles and responsibilities and associated strategic/tactical thinking.
Required Experience and Skills:
- Education Requirements: Minimum of Bachelor Degree
Preferred Experience and Skills:
- Minimum of 8 years of manufacturing, technology, and/or quality operation experience within an FDA, and/or EU API, Drug Product, Medical Device or equivalent environment.
- Quality/compliance experience in an FDA and/or EU regulated industry
- Experience performing audits of external and internal manufacturers and testing laboratories. Must have a working knowledge of processes to support the manufacturing of APIs and Drug Products.
- Thorough understanding of Quality Management Systems for API's, drugs products, and medical devices, including risk management. Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
- Ability to travel globally approximately 50% of the time.
- Ability to work independently with limited supervision in a virtual-management environment
- Must possess "Subject Matter Expertise", including knowledge and demonstrated application in one or more of the following areas; Medical Device/Combination product, Biologics, Vaccines, or API's or Non Sterile or Sterile Drug Product manufacture
- Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels of organization
- Degree in Engineering, Biological, or Chemistry Sciences
- External engagement in regulatory or industry forums. Current with regulatory expectations and requirements.
- Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.
- Demonstrated ability to lead and drive results/impact for critical business / compliance initiatives
- Demonstrated ability for process improvement and to create/implement simple, compliant systems in a diversity of areas
- Experience with direct participation on interdisciplinary Due Diligence teams - with Sr. Mgt, inclusive of initial risk/compliance assessment based on documentation
- Lean six-sigma belt / demonstrated process improvement experience
- Knowledge and expertise in application of Quality Risk Management pertaining to auditing, above-site function/processes, or technical areas
- Knowledge of QBD development & submission requirements
- Experience with development, implementation and optimization of IT tools to deliver business outcomes/impact.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org. Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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