Digital MMD Compliance Lead (Director)

We are seeking an experienced and proactive compliance leader to oversee our divisional compliance team to ensure regulatory alignment across our technology landscape. In this role, you will operate with a high degree of independence while championing a culture of transparency and knowledge sharing. You will serve as the vital link between IT and our broader business functions, ensuring that daily operations and major structural investments meet our rigorous global compliance standards.

Responsibilities

• Build, lead, and mentor a high-performing team of compliance professionals. Successfully guide the team through ambiguity, competing priorities, and periods of complex organizational growth, fostering a resilient and adaptable team culture.

• Direct and oversee day-to-day IT operational compliance activities. Ensure that our ongoing IT processes, systems, and controls consistently meet internal standards and external regulatory requirements.

• Lead the IT compliance strategy and execution for large-scale capital investments. This includes ensuring all technology implementations for new facility builds and major upgrades to existing facilities are fully compliant from design through deployment.

• Act as the primary compliance liaison to key business units. Partner deeply with our Quality organization, the Global Engineering function, members of our Governance, Risk, and Compliance (GRC) team, and internal stakeholders to align objectives and streamline compliance efforts.

• Drive and manage global process improvement initiatives across the compliance landscape. This includes executing targeted, small-scale operational enhancements as well as steering large, complex, multi-regional enterprise programs.

• Drive compliance initiatives independently while maintaining open, transparent communication with leadership and stakeholders. Actively promote knowledge sharing across departments to elevate the organization’s overall understanding of IT compliance.

Required

• A bachelor’s degree (BA/BS) is required.

• A minimum of ten (10) years of progressive experience in IT compliance.

• At least five (5) years of direct experience leading and managing teams. Demonstrated ability to inspire and manage teams effectively during complex times of change, growth, and shifting prioritization.

• Demonstrated, deep knowledge of supporting and validating computerized systems within a global, highly regulated pharmaceutical environment.

• Expertise must extend well beyond US FDA regulations (e.g., 21 CFR Part 11). Must possess a comprehensive understanding of international health authority regulations and guidelines, including the EMA (Europe), MHRA (UK), and other relevant global standards (such as Annex 11, ICH guidelines, and GAMP 5 methodologies).

• A self-starter who excels at independent execution, values clear communication and transparent reporting, and possesses exceptional stakeholder management skills., Audit Management, Business Process Improvements, Data Modeling, FDA Regulations, Global Engineering, Governance Management, Information Systems Strategy, Information Technology Operations, Investment Compliance, IT Compliance Audit, IT Compliance Management, IT Performance Management, IT Security Compliance, Leadership, Pharmacy Regulation, Process Improvement Projects, Quality Assurance (QA), Regulatory Requirements, Stakeholder Relationship Management, Team Management, Technical Compliance

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

The salary range for this role is

$173,200.00 - $272,600.00

We aspire to be the premier research-intensive biopharmaceutical company. We’re at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals., 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.