Assoc. Director, Global cGMP & Compliance Auditing

Assoc. Director, Global cGMP & Compliance Auditing


Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Associate Director is responsible for achieving and maintaining qualification / certification status through robust training and continuing education programs to enable conducting audits of Human Health, Animal Health and Consumer Care 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 time frames. 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.

  • Schedule and perform assigned audits and ensure timelines for audit steps (pre-work, conducting audit, issuance of audit report, Corrective Action and Preventive Action receipt) meet established expectations.
  • Maintain a broad based expertise of cGMP’s, our Company 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, APls and Controlled Substances.
  • Obtain and maintain cutting-edge knowledge, application, and certification status for various technical/Quality auditing topics
  • Maintain awareness of evolving industry and regulatory trends/regulations. 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.
  • 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.
  • 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.

Education Minimum Requirement:

  • Bachelor’s Degree in Science, Chemistry, (Micro-) Biology, Engineering (or equivalent).
  • Minimum of 10 years of manufacturing, technology, and/or quality operation experience within an EU/FDA, and Biologics. Quality/compliance experience in an EU/FDA regulated industry.

Required Experience and Skills

  • Review and approve audit reports, if assigned.
  • Experience performing audits of external and internal manufacturers and testing laboratories. Thorough understanding of Quality Management Systems and process to support the manufacturing of Biologics and medical devices, including risk management.
  • Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
  • 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,
  • Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels of organization
  • Must have the ability to travel globally approximately 50% of the time.

Preferred Experience and Skills:

  • 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 Senior
  • Management, 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 Quality By Design development & submission requirements
  • Experience with development, implementation and optimization of IT tools to deliver business outcomes/impact.
  • Must be a change agent and able to adapt in a dynamic environment American Society for Quality certified

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

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.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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
EEOC GINA Supplement​
OFCCP EEO Supplement

OFCCP Pay Transparency Rule

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: No relocation

VISA Sponsorship:

Travel Requirements: 50%

Flexible Work Arrangements: Remote Work, Telecommuting

Shift: 1st – Day

Valid Driving License: Yes

Hazardous Material(s): no

Number of Openings: 1

Requisition ID:R46215

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Skills

Posted on

April 13, 2020