Director, Animal Health – Compliance Remediation and Support Job - United States
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 125-year legacy. 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.
Basic Functions & Responsibility
- This position is critical in Merck’s effort to create a simplified, integrated, user-centric global Quality Management System (QMS) for our human health products with an objective to enable consistently compliant product quality, continuous improvement and effective life cycle management.
- Act as a cross-functional leader to Simplify, Standardize & Sustain our Compliance Remediation and Support department. This Director will ensure cross functional alignment and act as change agent for Director, Animal Health Compliance and Remediation Support.
- Lead development and execution of significant innovation projects driving operational improvements related to all the topics supporting Animal Health – Compliance, Remediation and Support.
- Hold the overall responsibility for Animal Health, Compliance and Remediation Support CAPA and inspection readiness processes that is critical to ensure a standardized and sustained QMS. Support alignment for those chapters related to Animal Health and data integrity including alignments from Global QMS that may apply to Animal Health for inspection readiness, inspection support and remediation.
- Lead and direct Compliance Remediation Support group related to Animal Health to ensure robust processes are in place and in use to maintain CAPA management and remediation support. This includes authoring documents, data entry of metrics and CAPA supporting compliance, remediation, and support.
- Lead during efforts to support inspection remediation and CAPA management processes, demonstrated experience as a lead during Animal Health related inspections.
- Develop the strategy and lead the implementation of the CAPA management and remediation across the MMD network, GMP and AH activities including MRL; define the strategy for global requirements to drive harmonization of processes and systems
- Lead the implementation of Quality Management System(QMS) requirements related to CAPA Management and Compliance Remediation Support.
- Ensure quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company’s QMS processes and alignments with Animal Health related to GMP and DI requirements.
- Provide leadership and technical direction on regulatory GMP/GDP requirements
- Initiate, where appropriate, and lead communities of practice to drive best practice sharing and continuous improvements across the MMD network
- Develop and proactively identify, investigate and resolve trends and patterns before they impact compliance and supply; define and drive implementation of performance metrics, as appropriate, to measure performance across the MMD network
- Influence and advocate Merck’s position on CRS processes related to HA expectations through a strong network of external connections and effective external engagement
- Anticipate external trends through benchmarking and regulatory intelligence activities and prepare the company proactively for changes and continuous improvements
- Lead, Act, and Support activities to ensure robust processes are in place and in use to maintain the Merck CRS and associated documents
- Lead development and execution of significant innovation projects driving operational improvements; this will require cross-functional support within the Global CRS team and Global QA and External Affairs.
- Bachelor’s Degree in Science or related field. Master’s Degree in field (preferred)
- Thorough understanding of regulatory requirements for drugs, devices, biologics, including quality risk management and knowledge management
- Minimum of 15 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in leading manufacturing and/or quality roles and/or in Global Quality; experience in vaccines, biologics, devices and API regulations preferred
- Ability to accurately interpret and apply regulatory expectations for a robust and compliant QMS in a drug, device and biologics manufacturing environment
- Strong project management skills
- Capable of working and communicating effectively with all levels of the organization globally
- Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management
- Proven ability to influence effectively without hierarchical authority multi-functional professionals to drive harmonization and proactive compliance
- Proven ability to effectively initiate and drive change across the MMD network
- Self-motivated with a high degree of ownership and accountability for results
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
Job Title:Dir, Quality Assurance
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Whitehouse Station West, NA-United States
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Medical, Manager, Compliance, Animal Health, Law, Healthcare, Management, Legal, Veterinary