Senior Director, Stability Operations and Device Program Management

Job Description

Pharmaceutical Analysis and Digital Technologies (PADT) is seeking an exceptional scientific and operational leader for the role of Senior Director Stability Operations and Device Program Management. This position will provide strategic ownership and end-to-end leadership for stability operations across the development portfolio through commercialization while also leading device program management activities that enable integrated delivery of drug-device combination products and associated analytical technical and regulatory deliverables.

The successful candidate will lead a team of scientists operational experts and program management professionals responsible for building and executing a robust compliant and scalable stability operations model. The role will require strong people leadership cross-functional influence portfolio-level prioritization and the ability to translate complex development needs into clear operational plans that support product quality regulatory submissions clinical supply and lifecycle management.

The scope of this position includes strategic oversight of stability study design protocol execution sample management stability data governance operational readiness and inspection preparedness for development programs across addition the Senior Director will partner with device development CMC regulatory clinical quality manufacturing and external partners to ensure device program plans are integrated with product development strategies key milestones are delivered and risks are proactively managed.

The Senior Director will oversee the technical writing and change control team ensuring timely delivery of BLA authoring global change controls and technical documentation. The role will set documentation standards manage portfolio priorities and partner with the digital team to support digital CMC and modernize the commercial filing strategy. These activities will support regulatory submissions inspection readiness and efficient execution of product and process changes.

Primary Responsibilities
Responsibilities include but are not limited to:

• Provide strategic scientific operational and people leadership for stability operations and device program management across the development portfolio.

• Establish and maintain an integrated operating model for stability study planning protocol execution sample logistics storage testing coordination data review and reporting.

• Lead device program management activities to ensure clear plans governance risk management decision making and milestone delivery for drug-device and combination product programs.

• Partner with cross-functional development teams including CMC regulatory clinical quality manufacturing supply chain device development and external partners to align stability and device deliverables with program objectives.

• Ensure stability operations and device program management practices are inspection ready compliant with applicable GxP expectations and aligned with internal quality systems and regulatory commitments.

• Develop and implement portfolio-level metrics dashboards and governance routines to monitor delivery identify risks drive continuous improvement and support transparent communication with senior stakeholders.

• Build mentor and develop a high-performing inclusive team with the scientific operational and program management capabilities required to support a complex and evolving development portfolio.

Education Minimum Requirements

• Ph.D. degree in Chemistry Pharmaceutical Sciences Engineering Biology Biochemistry or related scientific discipline with 10 years of relevant experience.

• MS degree with 13 years of relevant experience.

• BS degree with 16 years of relevant experience.

Required Experience and Skills

• Demonstrated ability to lead large inclusive cross-functional scientific or operational teams and to attract develop and retain talent.

• Extensive experience in pharmaceutical development stability operations analytical development CMC quality regulatory or related technical disciplines.

• Strong working knowledge of stability requirements GxP expectations regulatory guidance product quality principles and inspection readiness practices.

• Experience leading complex programs managing portfolio-level priorities and influencing senior stakeholders across functions and geographies.

• Ability to integrate scientific technical operational regulatory and business considerations into clear program strategies and executable plans.

• Excellent verbal and written communication skills with the ability to present complex information clearly to technical teams governance forums and senior leaders.

Preferred Experience and Skills

• Proven track record leading stability operations analytical operations device development combination product programs or cross-functional CMC program management in a regulated pharmaceutical environment.

• Experience developing operating models governance processes metrics and continuous improvement initiatives that improve delivery compliance and portfolio transparency.

• Experience supporting regulatory submissions health authority interactions inspections or product lifecycle activities related to stability analytical device or combination product deliverables.

Position Scope
This Senior Director role has enterprise-impacting scope across PADT and partner functions with accountability for establishing the strategy operating model governance and performance expectations for stability operations and device program management. The role will ensure that stability and device-related deliverables are integrated with CMC development plans regulatory strategies clinical timelines supply needs and quality expectations. The incumbent will be expected to operate as a senior leader sponsor cross-functional problem solving and drive consistent execution across internal and external networks.

Required Skills:

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 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

EEOC GINA Supplement

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 anothers 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

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 employees 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 can apply for this role through (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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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