Job Description
We're looking for a
Director of Quality Assurance
to lead quality across the full value chain for a late‑stage ophthalmic program. In this role, you'll be a core member of the Value Chain Management Team, guiding strategy, ensuring compliance, and enabling manufacturing excellence from development through commercialization. You'll partner across Quality, Regulatory, Technical, and Supply Chain teams—coaching, facilitating, and removing obstacles so the program can thrive.
Bring energy, knowledge, innovation to carry out the following
* Own the product's quality strategy, aligned to supply strategy, and ensure clear documentation and execution
* Shape the analytical strategy (labs, testing approaches, stability) and support site selection
* Provide hands‑on quality leadership to product and focus teams; advise, problem‑solve, and drive continuous improvement
* Implement and oversee fit‑for‑purpose Quality Management Systems and standard ways of working
* Stay current on regulations and apply them pragmatically; support inspections and champion ongoing inspection readiness
* Partner with Corporate Quality and other sites to share best practices and align on quality systems
* Lead quality communications across the network; run meetings, surface risks, and escalate issues when needed
* Track and interpret key metrics (changes, complaints, annual product reviews) to identify trends and mitigate risk
* Review and approve cross‑site evaluations and post‑marketing assessments
* Monitor franchise quality risks and performance with site quality teams
* Represent Quality on the Value Chain Management Team and related working groups; lead or contribute to chartered projects
What Skills You Will Need
In order to excel in this role, you will more than likely have
* 10+ years in the pharmaceutical industry with proven leadership experience
* Deep quality expertise; experience with ophthalmic or large molecules is a plus
* Background in continuous improvement or analytics is helpful
* Strong project management, communication, and stakeholder skills
* Experience leading cross‑functional teams to deliver on strategic initiatives
* Degree in a science, pharmacy, or engineering discipline; advanced degree welcome
* Track record of driving change and measurable improvements
* Commitment to professional growth and continuous learning
* Collaborative mindset and ability to build trust across diverse teams
* Travel requirement
* Willingness to travel 10-15% for assignments outside your primary location, including short-term travel as needed
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application.
So, if you are ready to
Invent solutions to meet unmet healthcare needs,
please apply today
.
Required Skills
Communication, Entrepreneurship, Execution Excellence, Influence, Leadership, Networking and Partnerships, Program Management, Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance, Risk Management, Stakeholder Management
Preferred Skills
Current Employees apply HERE
Current Contingent Workers apply HERE
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
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid
Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
11/26/2025
* A job posting is effective until PM 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.
Requisition ID
R372886