Executive Director, MRL QA Standards & Operations Job

Employer
Merck
Location
Rahway, NJ, US
Posted
October 05 2017
Discipline
Other
Organization Type
Pharma
Executive Director, MRL QA Standards & Operations-QUA006307

Description

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.

Under the direction of the Head of MRL Quality Assurance, this Executive Director serves as the Business Strategy and Operations Lead for MRL QA. S/he provides operations support, including strategy and innovation, metrics, communications/change management, and meeting management to the Head of MRL QA and the overall MRL QA Leadership Team. S/he collaborates with the Head of MRL QA to define the strategic direction for MRL QA activities, and then in partnership with the MRL QA Leadership Team drives the execution of the activities through the use of metrics and tools. S/he is accountable to develop and advance the MRL Quality Management System and oversight to the activities associated with Quality Systems and partnering/influencing with the broader Merck Quality Areas for alignment. This role will also be the leader of SOP management and training for MRL QA. The Executive Director plays a critical role in driving the strategic direction and priorities for the MRL QA organization.

Primary activities include but are not limited to the following:

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Oversee the strategy management system within MRL QA – strategy planning meetings, balanced scorecard, departmental objectives and alignment, including periodic reviews and appropriate communications.

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Collaborate with Finance and MRL QA Leadership Team to develop, track and revise, as needed, the CMC budget with a focus on headcount targets.

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Serves as MRL QA Leadership Team meeting facilitator. Identifies and prioritizes issues, ensures alignment, coaches individuals with assignments/projects, and tracks assignments/projects to satisfactory completion and/or realization.

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Lead the Business Operations Team, providing planning, coordination, and communication to ensure the successful alignment and implementation of key strategic initiatives. Ensure appropriate metrics are established to track installation and realization. Provide planning, coordination and communication support to ensure successful alignment and implementation of key strategic initiatives.

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Responsible for coaching and mentoring individual contributors and managers within the team, as well as operate in a matrix management environment to progress organizational and strategic projects with high impact and high visibility to global stakeholders. Ensure successful execution of objectives, provide timely feedback to employees, and focus on the development of the employee by facilitating regular development discussions.

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Responsible for MRL Standards long term strategy and execution for long term sustainability (e.g., training, governance, curricula) and oversight.

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Lead the development and management of MRL QA SOPs and associated training.

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Responsible for MRL QA Operations support, strategy, metrics, communications, change management, and meeting management.

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Responsible for the advancement and oversight of the MRL Quality Management System, including QMS interfaces with Merck Manufacturing Division, Global Human Health and Animal Health.

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Responsible for the development, evolution and management of the MRL Quality Dashboard and the quarterly compilation and advancement of the dashboard.

Qualifications

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Bachelor's degree required, with a concentration in a scientific-related discipline strongly preferred. Advanced scientific degree (e.g., MS, PharmD, Ph.D.) or a combination of equivalent experience and training preferred

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15+ years clinical development oversight experience or relevant experience in clinical quality management, biomedical science, clinical development, or regulatory strategy; equivalent experience

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5 + years experience working with and directly communicating with senior leaders with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities

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Demonstrated teaching and coaching capabilities, and experience as a manager of people

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Proven ability to function autonomously at a senior level in a matrix model and in a team environment

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Proven business management capability

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Proven ability to think creatively and to develop and execute strategic plans

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Demonstrated ability to build relationships with senior business executives. Relationship management and networking: strong integration into headquarter network and ability to build productive relationships with all parties

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Excellent interpersonal and communication skills. Ability to prioritize, align and simplify

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 an accommodation for the application process please email us at staffingaadar@merck.com.

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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Quality Assurance

Job Title:Executive Director, Quality Assurance

Primary Location: NA-US-NJ-Rahway

Other Locations: NA-US-PA-Upper Gwynedd

Employee Status: Regular

Number of Openings: 1

Company Trade Name:Merck

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