Associate Director, Quality Systems & Compliance (Design Controls)

Job Description

Brief Description of Position

The Associate Director Quality Systems & Compliance within Device Quality & Regulatory will support our company's Manufacturing Division QMS Topic 3.3 – MDCP Design Controls and lead continuous improvement initiatives that support every aspect of our business processes, systems, and data.

The Associate Director will collaborate with cross-functional teams to identify opportunities for improvement, address internal/external audit observations and tackle challenges, balancing effective operations with transformative initiatives.

The Associate Director will work with the manufacturing division's Topic 3.3 Owner and Business Owner and has responsibility for oversight and lifecycle management of procedures related to this specific topic within the QMS including the document change control/implementation process and maintenance of the Global Training Plan/courses. They act as subject matter expert and collaborate with the global QMS Topic 3.3/Chapter/Topic/Business Owners and Topic 3.3 CoP Owner to align with global requirements and ensure site/function compliance to the global QMS topic.

Activities include attending Topic 3.3 Community of Practice (CoP) meetings, QMS Chapter 3 meetings, MDCP Site Communication meetings, and Document Control Technical Committee meetings to ensure compliance with current Good Manufacturing Practices (cGMPs), ISO 13485 requirements, and other Global Health Authority Regulations.

Accountable for other Quality Programs, as assigned.

Primary Activities include, but are not limited to:

• Bring knowledge from the QMS Topic back to the Chapter 3.3/Topic 3.3/Business owners, site/function to drive compliance and continuous improvement.

• Communicate and address impact for issues related to QMS updates within the site/function and delays to QMS targets.

• Complete follow-up actions, such as gathering information on WoW, completing implementation surveys, and providing requested input.

• Routinely reports the health of the topic such as site/function level topic implementation, topic effectiveness, trends etc. to the QMS Topic/Business Owner and develop continuous improvement plans as needed.

• Support the identification, resolution, and escalation of any issues to meet QMS requirements.

• Share knowledge, best practices and inspection experiences including answering Barnum questions to foster a culture of continuous improvement.

• Participate in cross-functional global teams for the development and continuous improvement and optimization of the topic.

• Identify and communicate ideas for future Community of Practice discussions.

• Submit Bright ideas for continuous improvements and actively participate in solution generation.

• As applicable, support observation responses and ensure timely CAPA implementation.

• Perform other activities, as assigned.

Education Requirements:

• B.S. and/or M.S. degree in an appropriate Science or Engineering discipline with a minimum of ten (10) years of experience with in-depth knowledge of pharmaceutical, medical devices and/or medical devices and combination products.

Required Skills & Experience

• 3 years relevant experience including Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical, medical device and combination products; or related fields.

• Preferred experience in the assessment of US FDA 21 CFR Part 4 and Part 820, EU MDR:2017/745, ISO 13485:2016, ISO 14971:2019 for review of Quality Management System documents for our manufacturing division's Quality Manual and Device Network Quality Manual.

• Knowledge of IEC 62304: Medical Device Software Life-Cycle Processes.

• Must have strong knowledge of regulations listed above and be able to work in a team environment identifying gaps in the QMS documents.

• Working knowledge for the design, manufacture, packaging, purchasing, testing, release, storage, and distribution of medical devices and/or medical device combination products.

• Must be able to build relationships within a team environment.

• Experience using computer systems for Quality Management Systems.

• Must have working knowledge of regulatory expectations for the design, manufacture/packaging and distribution of medical devices or medical device combination products with experience in quality assurance or regulatory oversight of these products.

• Experience authoring, reviewing, and approving Quality Management System documents.

• Solid organizational skills including attention to detail and multi-tasking skills.

• Effective people skills and ability to work collaboratively across diverse teams and networks, able to foster cooperation in others.

• Effective written and oral communicator, ability to speak up and contribute in a team forum.

Required Skills:

Adaptability, Business Processes, Business Process Management (BPM), Combination Products, Cross-Cultural Teams, Design Controls, Driving Continuous Improvement, Global Team Collaboration, GMP Compliance, Good Manufacturing Practices (GMP), Medical Devices, Quality Management Systems (QMS), Risk Management

Preferred Skills:

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

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

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

$129,000.00 - $203,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date:

06/10/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.