Regulatory Affairs Director - MSD

This position will lead and support activities involved in the design/development, implementation, governance and sustainment of a harmonized Quality Risk Management (QRM) program including standards, business processes, tools, and training for our company's External Manufacturing and External Quality Assurance organizations.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Responsibilities include, but are not limited to:

• Develop Quality Risk Mangement (QRM) expertise through completion of assigned training and tasks to serve as a Subject Matter Expert for MSD’s External Manufacturing and External Quality Assurance organizations.
• - Partner with QRM Center of Excellence and other QRM personnel to ensure that departmental business processes developed are implemented and aligned with approved QRM documents in the Quality Management System. 
• - Partner with QRM Center of Excellence and other QRM personnel to develop and deliver training on tools and businesses processes to be utilized by MSD’s External Manufacturing and External Quality Assurance organizations.
• - Provide guidance for the facilitation of QRM strategies for complex or cross-site/cross-product risk management in MSD’s External Manufacturing organization.- Plan, lead, and coordinate performance of Quality Risk Assessments, where required.
• - Partner with customers, key stakeholders, and management, to communicate/escalate identified risks to ensure adequate resource allocation (where required) and timely resolution.
• - Sub-System Owner for QRM Chapter within the Quality Management System.
• - Provide continued support to organizational personnel to enable sustainability of the QRM program.

Education Minimum Requirement: 

Bachelor’s degree in science, engineering, or related areas of study.

Required Experience and Skills: 

• Minimum of five (5) years of relevant experience in the pharmaceutical, biopharmaceutical, medical device, or related industry.
• - Expert knowledge of cGMPs and/or Quality System regulations
• - Ability to work independently with all levels of the organization
• - Experience collaborating cross-functionally to develop and/or drive successful programs
• - Strong customer-focused mindset
• - Willing to identify and drive continuous improvements
• - Ability to handle multiple assignments

Preferred Experience and Skills:

• Demonstrated capabilities in facilitation, preferably risk assessments using risk management tools per ICH Q9 guidelines (FMEA, PHA, Risk Rank and Filtering, etc.)
• - Experience with on the floor manufacturing processes
• - Ability to demonstrate good quality judgement in collecting and synthesizing relevant data and information and make independent and timely decisions; communicates, influences, and escalates issues and decisions as needed
• - Accountable for actions and driving results in a dynamic environment with the ability to learn from mistakes and resolve issues quickly.

Our Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.

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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.