Jobs for Veterans, Veteran Job Board | GiJobs.com

Post Jobs

Job Information

Merck Executive Director, Quality Assurance QMS in Rahway, New Jersey

Job Description

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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 our Research and Development Division Quality management system

  • Communication and interaction with all levels of our Research and Development Division to ensure an effective and efficiently operating quality system

  • Development, advancement, communication, maintenance of quality elements to ensure that our Research and Development division QMS meets/exceeds industry benchmarks

  • Development, advancement of the system and framework for oversight of our Reserach and Development Division's 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 our Research and Development Division 's 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

  • Assess the impact of workload, capacity, resources, roles and responsibilities on quality internally and externally

  • Serve as liaison/point of contact with/to other quality functions in our Research and Development Division (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 our Research and Development Division

  • Sets and oversees effective continuous improvement processes, procedure, practices, framework are in place across our Research and Development Division 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 our Research and Development Division

  • 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 our Research and Development Division 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

Education Minimum Requirement:

  • Required: Bachelor Degree

  • Preferred: Advanced degree

Required:

  • A minimum of 10 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

  • Effective communication at all levels of an organization

  • Leadership Development and Coaching

  • Talent Management

  • Driving operational excellence

  • Advancing quality culture

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .

INVENT.

IMPACT.

INSPIRE.

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

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

EEOC Poster at https://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf

EEOC GINA Supplement​ at https://www1.eeoc.gov/employers/upload/eeocginasupplement.pdf

OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf

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

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Travel Requirements:

10%

Flexible Work Arrangements:

Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R36935

DirectEmployers