Executive Director, Quality

2 days left

Recruiter
Merck Research Laboratories (mrl) Division
Location
United Kingdom
Salary
Competitive
Posted
28 Dec 2018
Closes
25 Jan 2019
Sectors
Management
Contract Type
Permanent
Hours
Full Time
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. MRL * Search * Previous Deputy Director of Finance | Barking Havering and Redbridge Univ Hospi * Field Service Engineer - Break Fix Next Executive Director, Quality Management Systems Recruiter Merck Location United Kingdom Salary Competitive Posted 21 Dec 2018 Closes 18 Jan 2019 Sectors Management Contract Type Permanent Hours Full Time Email me latest jobs 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. MRL Quality Assurance is the organization within Merck Research Laboratories (MRL) Division responsible for overseeing the divisional Quality Management System. The MRL Quality Management System is the foundation for ensuring leadership and organizational commitment to quality. This executive director role resides in MRL, reports to the Head of Strategy and Business Operations within Quality Assurance and is closely aligned with the broader QA organization as well as all of the functional areas within MRL (i.e. DPED, GPAM, GCD, GMA, BDL, CORE, GRACS). The mission of the Quality Assurance organization is to: Safeguard the Rights and Well-Being of Patients, the Welfare of Animals, and Comply with Applicable Global Regulatory Requirements through Sound Processes and Procedures. Further, Quality Assurance provides independent oversight to assure that Merck delivers high quality data and clinical supplies. Proven successful track record with the following: * Leading, transforming an efficient effective pharmaceutical and or Bio-tech R & D Quality Management System * Transforming, designing and implementing quality systems to improve overall performance while reducing quality and/or compliance risk in a diverse business environment and culture * Driving Quality by Design approach to both GxP and non-regulated work activities * Deploying effective management controls, governance processes * Supporting regulated business matters with US and other health authority or regulatory agencies * Interpreting GMPs, GLPs, GPVPs and GCPs and relevant topics such as documentation practice and data integrity * Leading cross-functional committees with diverse set of individual priorities * Improving processes for greater efficiency and effectiveness and establishing best practices * Managing a team of individual contributors * Driving quality practices as a competitive advantage Key Responsibilities may include but are not limited to: * Quality development, advancement and oversight of the MRL Quality management system * Communication and interaction with all levels of MRL to ensure an effective and efficiently operating quality system * Development, advancement, communication, maintenance of quality elements to ensure that MRL QMS meets/exceeds industry benchmarks * Development, advancement of the system and framework for oversight of MRL Policies, Processes, Procedures * Lead and manage the Standards Committee, a cross-functional team of delegates with a diverse set of priorities, to drive decisions and streamline MRL documentation practices * Develop, advance framework for effective quality governance inclusive of communication and escalation * Ensure adequate quality and oversite practices are in place and followed for internal work as well as third party vendors, CROs, service providers * Assessment of the impact of workload, capacity, resources, roles and responsibilities on quality for internal and externally * Liase/point of contact with/to other quality functions in MRL (DPED, GPAM, GCD, MA, BDL, CORE, GRACS) * Set and oversee effective processes, procedure, practices, framework are in place for quality risk management (mitigation and minimization), issue management (identification, prioritization of issues that matter, root cause analyses and resolution) , * Set and oversee effective processes, procedure, practices, framework are in place for knowledge management, documentation * Surveys, communicates and ensures discussion and interpretation of new and emerging regulations and informs/communicates such information along with any planning/implementing strategies across MRL * Sets and oversees effective continuous improvement processes, procedure, practices, framework are in place across MRL and drives continuous improvement activities for QA * Understand the phases, processes and techniques used to execute a Quality Assurance Plan across the GxPs and ensures these are implemented and adhered to as part of quality oversight; * Develops and provide training for QA and ensures that training is adequate and available across MRL. * Refine and develop effective Policies, SOPs, Execution Resources (and other) and create training materials/workshops, as well as, the associated infrastructure for the Division; * Develop, manage, and execute audit methods, process, procedures and training * Work with LT to develop, continuously improve and implement training ensuring compliance with processes executed by QA and MRL Staff * Works with the Leadership Team (LT)to continually improve QA tools and processes * Develop, coordinate, and host regular continuing education and development opportunities for QA staff * Manage and develop team of 2-3 individuals * Serve as ad hoc participant at the VP Quality Assurance LT meetings Executive Director MRL Quality Management Systems- Experienced Leader with a demonstrated successful history of building and advancing quality management systems, processes and documentation practices in the pharmaceutical industry., Education Requirements: * Required: Bachelor Degree * Preferred: Advanced degree, Technical Specialization/Experience: * A minimum of 15 years GxP R&D experience in Pharmaceutical and/or Bio-Tech * Quality Management Systems and implementation (including redesign) * Quality, Ethics & Compliance, Research Integrity * Auditing functions * Crisis/Issue management * Risk-based decision making * CAPA processes * Quality/Compliance Metrics (e.g. KQIs, KPIs) * Process improvement * Project management, 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. Leadership competencies: * Effective communication at all levels of an organization * Leadership Development and Coaching * Talent Management * Driving operational excellence * Advancing quality culture 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. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to . Share * Facebook * Twitter * LinkedIn * Google+ Sign up for job alerts Get new jobs for this search by email Email jobs Apply Sign up for job alerts Get new jobs for this search by email Email jobs successful history of building and advancing quality management systems, processes and documentation practices in the pharmaceutical industry., Education Requirements: * Required: Bachelor Degree * Preferred: Advanced degree, Technical Specialization/Experience: * A minimum of 15 years GxP R&D experience in Pharmaceutical and/or Bio-Tech * Quality Management Systems and implementation (including redesign) * Quality, Ethics & Compliance, Research Integrity * Auditing functions * Crisis/Issue management * Risk-based decision making * CAPA processes * Quality/Compliance Metrics (e.g. KQIs, KPIs) * Process improvement * Project management, Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity..... click apply for full job details

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