Job Description

We are seeking a Growth and Improvement minded Global Quality and Compliance Associate 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

This position is critical in our Company’s effort to create a simplified, integrated, user-centric global Quality Management System (QMS) for our human health products, with an objective to enable consistently compliant product quality, continuous improvement, and effective life-cycle management. The Associate Director, Quality Assurance for the Training and Qualification topic will provide support to the Training and Qualification system codified in our Company Quality Manual, monitor the performance of the quality system, and drive continuous improvement efforts.

The position will monitor site adherence to the company’s codified Training and Qualification quality system, champion standard work across all sites and assist sites in the troubleshooting site-based Training and Qualification issues. The person will lead a Community of Practice, develop and maintain global training materials, and be a knowledgeable on information systems supporting Training and Qualification.

Key Functions

• Monitor health authority regulations and ensure that relevant regulations are incorporated into the Training and Qualification Quality Management System documents.
• Author and maintain global Training and Qualification topic documents.
• Ensure procedures are aligned with other Quality Management System topics and functionality updates to the IT platforms supporting the Training and Qualification process.
• Interact with other QMS Topic Owners to drive further integration of Training and Qualification processes with their topics. Develop and maintain global training materials on the Training and Qualification system and deliver training to our Manufacturing Division personnel, as needed.
• Lead a community of practice for Training and Qualification and manage the content of information placed on the CoP’s website. Troubleshoot site-based Training and Qualification issues and provide guidance on resolution. Interface with Information Technology group to identify system improvements that enhance the efficiency and effectiveness of the Training and Qualification process.

Minimum Required Education and Experience

• Bachelor of Science (BS) degree in a relevant field of science or engineering with seven (7) years in pharmaceutical and/or vaccine manufacturing environment; OR
• Master of Science (MS) degree in a relevant field of science or engineering with five (5) years in pharmaceutical and/or vaccine manufacturing environment

Required Experience, Skills, and Knowledge

• Demonstrated leadership in Quality & Compliance discipline and in-depth knowledge of global health authority regulations and requirements, with the ability to effectively translate and communicate these requirements.
• A continuous improvement mindset and bias to action.
• Demonstrated management/leadership skills.
• Strong communication skills.
• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.
• Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
• Capable of working and communicating effectively with all levels of the organization globally.
• Capable of facilitating global forums and maintaining effective Communities of Practice, Common Interest Groups, and other Knowledge Management solutions.
• Experienced with data analytics, development, and use of visualization tools to convey performance messaging.

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.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, 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.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A