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Associate Director, Quality Assurance | Improvement Engineering

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.

Primary Responsibilities

Ensure an appropriate design, implementation and execution of a prioritized Large Molecule Quality Hoshin comprised of United States Large Molecule (LM) regional initiatives i.e.:

  • Testing locations (optimizing and leveraging the network: testing hubs/local testing)
  • Testing operations (Lean lab)
  • Operationalizing Quality Assurance (QA) activities
  • Right sized & right scope of Quality Investment projects (Equipment, QC labs, animal facilities)
  • To be successful, build and maintain sponsorship with the relevant stakeholder groups within Quality, Operations and support functions, coordinating and aligning individual activities across the network

Governing Hoshin initiatives from end-to-end, building and maintaining meaningful Key Performance Indicator (KPIs) to monitor progress (visualization) and to identify risks or opportunities to ensure compliant customer supply. In the network, you will

  • Partner closely with LM Animal Health Operations to ensure consistency between Operations and Quality.
  • Partner with Operational Excellence Teams in other areas (e.g. Small Molecule sites, Human Health) to ensure leveraging of best practices and approaches.
  • Partner with other Global support functions such as Global Supply chain (e.g. Agility; mid-term and long-term planning), Technological Support (testing improvements to ensure meeting strategy for commercial testing), R&D (development of right tests for commercial testing) and others as appropriate
  • Participate in Business review meetings throughout our Manufacturing division to identify critical projects and processes for Quality, which would benefit from improvement.
  • Support and ensure collaboration and exchange of best practices across the network.
  • The position requires traveling to the Animal Health sites up to 50%. The base can be determined by your current location. If applicable relocation will be supported by us.

Education Minimum Requirements

  • Bachelor Degree in Engineering or Life Science

Required Experience and Skills

  • Knowledge of Lean Six Sigma
  • Proven ability to manage complex projects
  • Sound and ethical ability to influence people and initiate and drive change in complex organizations
  • Effective verbal and written communication skills in English
  • Ability to build resilient relationships within and across functions with proven ability to influence senior levels of plant management
  • Innovative and strategic thinker with successful problem solving skills

Preferred Experience and Skills

  • 3+ years of relevant work experience in projects or global projects in operational excellence with use of Lean concepts
  • 5+ years’ experience in USDA Animal Vaccine manufacturing or operations

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:

Domestic

VISA Sponsorship:

Travel Requirements:

50%

Flexible Work Arrangements:

Remote Work

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R36818

Associate Director, Quality Assurance | Improvement Engineering

Worthington, MN
Full Time

Published on 03/05/2020