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 dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

We are seeking Growth and Improvement minded Global Quality Compliance Director that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary, Focus and Purpose

The Global Quality Compliance Director will be part of the Microbiological Quality & Sterility Assurance organization, a Quality Assurance group that has global responsibility for microbial control and sterility assurance related topics. In the Director role, you will provide leadership and direction for microbiology related topics in biologic, vaccine sterile, non-sterile manufacturing and/or microbiology laboratories for assigned topics. You will lead the development, deployment and maintenance of multiple divisional quality standards and divisional policies to ensure our Company's Manufacturing Division is compliant to cGMPs for these topics and also lead divisional projects across internal and external sites.

The Global Quality Compliance Director leads development of strategy to drive compliance and continuous improvement in the network and delivers support for regulatory inspections and responses. This role will require collaboration and global coordination of work across Quality and above site groups. Responsibilities contain Quality, regulatory, and business elements.

Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Developing, authoring, and maintaining the divisional quality standards in alignment with regulatory requirements, cGMP expectations, and industry trends

• Assisting manufacturing sites and project teams with project strategy, regulatory interactions, development of responses to inspection observations, QMS compliance, significant microbiological investigations, and guidance

• regarding corrective actions

• Leading company initiatives and projects to improve compliance and consistency in practices across the company in the designated area of expertise

• Participating in external industry and regulatory forums to stay abreast of industry trends

• Establishing/maintaining industry-leading expertise in the designated subject area(s)

Education

• B.S., M.S. or Ph.D required | Preferably in Science or Engineering such as Microbiology, Biology, Biochemical Engineering, Pharmacy, or related science discipline

Experience | Skills | Knowledge

Required

• Must be experienced in one or more subject areas including low bioburden operations, sterile/aseptic manufacturing and facility design, microbiological contamination control, sterile/aseptic manufacturing and facility design, environmental monitoring, cleaning and disinfection and critical utilities

• Ten years in pharmaceutical, biopharmaceutical, vaccine or medical device industry

• Technical problem-solving abilities

• Principled and strong communications, planning and collaboration/negotiation skills

• Technical writing proficiency

• Knowledge of international GMPs and Quality Management requirements of various regulatory agencies (e.g. US FDA, EMEA, TGA, PMDA, etc.) as well as USP compendia, EU compendia and ISO industry standards

• Ability and willingness to travel to the manufacturing sites in USA, Europe, Latin America and /or Asia for up to 20% of the time

Preferred

• Advanced subject expertise in one or more of the following areas: low bioburden operations, microbiological contamination control, sterile/aseptic manufacturing and facility design, environmental monitoring, cleaning and disinfection, critical utilities, microbiology methods

• Highly experienced in regulatory inspections and response preparation

• Strong leadership capabilities and ability to work cross functionally to develop solutions and champion a position

• Demonstrated ability to effectively work hands-on with shop floor personnel. Ability to upskill individuals on topics such as microbiological methods, requirements/regulations, microbiological contamination control

• Quality Risk Management knowledge and experience

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

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

Residents of Colorado

Click here to request this role’s pay range.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.

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Relocation:

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Requisition ID:R224766