Senior Specialist, Quality and Compliance Improvement Programs

Senior Specialist, Quality and Compliance Improvement Programs


Job Description

Summary of Responsibilities:

This individual will be responsible actively supporting compliance initiatives for US-based veterinary biologics manufacturing facilities, regulated by USDA and international veterinary health authorities.  This role will serve as project manager for all ongoing programs, as well as a substantive contributor to the design and execution of the programs. Program assignments may be varied but all will include the development and/or implementation of continuous improvement projects and the practical application of USDA and international regulations and guidelines. This position will report to the Executive Director, Quality and Compliance Improvement Programs. Project team members will serve as leaders, mentors and coaches to ensure project goals are achieved.  Project team members will provide expert guidance and support to sites as they execute the project action plan.

The project team member will:

  • Serve as the project manager for ongoing projects, ensuring coordination, progress tracking, and metrics/   supporting the site(s), RA, and project leadership.
  • Develop and maintain project plans, negotiate solutions with sites to resolve delays and escalate issues to leadership. Maintain program metrics to monitor progress against targets
  • Schedule and coordinate project team meetings (e.g. tier/status updates, coordination meetings, management meetings, oversight committee meetings, etc.)
  • Lead the development and implementation of a USDA integrated product information system
  • Contribute to the continuous improvement of the conformance project processes.
  • Provide training and coaching to site personnel as needed to support project goals.
  • Contribute to the development of new standard procedures, work instructions, execution tools, training materials, and/or guidance documents.
  • Ensure gaps are assessed per internal procedures, including any requirements for regulatory notification
  • Ensure consistency of output from sites through quality assurance reviews and feedback to review teams
  • Other duties as assigned.

Education Requirements:

  • Minimum Associate’s (2 year) degree in science, engineering, or related areas of study. Bachelor’s degree and/or Project Management certification preferred.

Required:

  • 8+ years’ experience in Animal Health, biological vaccine manufacturing, quality control, regulatory affairs and/or quality assurance
  • Has experience with project management
  • Is knowledgeable of USDA regulations and requirements
  • Is knowledgeable of or willing to learn international regulatory requirements
  • Is detail oriented and critically thinking
  • Is self-motivated and able to work independently
  • Has some experience leading-through-influence, remotely and in-person, to meet desired outcomes. Experience with remote working tools, such as web conferencing.
  • Is willing to challenge the status quo and exploring continuous improvement opportunities

This position may be required to travel and work at multiple US sites.  Travel requirements could exceed 50%, and remote communication tools should be used as much as possible.

Remote work arrangements may be considered.

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.

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:

No

Travel Requirements:

50%

Flexible Work Arrangements:

Flex Time, Remote Work, Telecommuting, Work Week

Shift:

Valid Driving License:

Yes

Hazardous Material(s):

NO

Number of Openings:

1

Requisition ID:R36733

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Skills

Posted on

February 6, 2020