Senior Director, Quality Assurance

Merck & Co.; West Point (PA); Vor Ort; USD 173.000 - 273.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays & vacation

Zusammenfassung

Merck in the United States is seeking a Senior Director, Biologics, DP, & Device Platform Lead for TPQM & DD to provide strategic and operational leadership over third-party quality management across biologics and devices, ensuring regulatory compliance and risk mitigation in the clinical supply chain.

You will lead a team of 9+ professionals, collaborate with vendors and stakeholders, drive continuous improvement, and navigate complex quality challenges; hybrid work with travel up to 25%.

Qualifikationen

• Bachelor's degree in engineering, Biology, Chemistry, or related field.
• A minimum of 10+ years of relevant pharmaceutical industry experience, or 8+ years with advanced degree.
• Experience interacting with regulatory officials and external auditing parties.

Aufgaben

• Execute daily operational TPQM support for biologics drug substances and sterile/non-sterile products.
• Develop and drive quality strategies and improvement initiatives.
• Support Global Auditing group with audits and mitigation of observations.
• Collaborate with senior management on quality/regulatory matters and cross-functional projects.
• Coach and develop team members in quality leadership.

Kenntnisse

Coaching

Compliance Reporting

Detail-Oriented

External Manufacturing

Leadership Theories

People Leadership

Quality Management

Strategic Objectives

Ausbildung

Bachelor's degree in engineering, Biology, Chemistry, or related field

10+ years of pharmaceutical industry experience

Experience with regulatory officials & external auditing

Jobbeschreibung

Job Description

The Senior Director, Biologics, DP, & Device Platform Lead, Third Party Quality Management & Due Diligence (TPQM & DD), Global Development Quality is responsible for providing expert strategic, scientific and operational leadership to teams.

This position will lead strategic operational initiatives, build talent across the organization, and the overall operational and strategic oversight of third-party contractors and vendors providing biologic drug substance, sterile and non-sterile bulk drug product, and medical device and combination product including design and assembly in support of our Company 's clinical supply chain.

This position is responsible for a team of >9 professionals. Key areas of responsibility include defining and driving the quality performance and ensuring compliance robustness on behalf of TPQM across a designated vendor base. This includes supporting the development and execution of a strategic global vision for TPQM and influencing the same for key stakeholder in multiple business areas.-

This role will provide specific quality support and be responsible for supporting the development and driving the execution of the continuous improvement of third-party quality processes within a high-impact vendor base to minimize and mitigate risk to our Company development programs.

Primary Activities:

The position will require an in-depth close collaboration with the vendor quality and technical personnel and associated interaction with their functional equivalents in the specific source area on executing against strategic objectives related to the designated vendor base.-This will also include navigating technically highly complex quality related matters, both process improvements and significant quality issues and events.- Supervise a group of ~9 Quality professionals .

An advanced level of knowledge of the clinical development process and of the associated stakeholder organizations is required for this role in addition to technical and quality expertise and experience to enable the incumbent to carry the necessary level of credibility to the stakeholder areas as well as with the vendors at senior levels to be successful.

In addition to the high-level responsibilities discussed above, the incumbent is expected to independently execute on-the following :

• Execute the daily operational TPQM support for the biologics drug substance and sterile and non-sterile drug product vendor bases related to the most complex activities that our Company outsources, with the associated potential for high impact to the development portfolio.
• Supporting the development of and driving the execution of quality strategies, improvement initiatives in line with business drivers and objectives.
• Provide close support to our Company 's Global Auditing group in relation to audits conducted and mitigation activities in regard to audit observations for the designated vendor base.
• Interacting cross-functionally and cross-divisionally with senior management on quality/regulatory matters as well as special projects, and externally with inspectors and colleagues in industry in relation to the designated vendor base.
• Driving the resolution of contractor / vendor related business practice, Quality and/ or compliance issues of high-impact scope and highest level of complexity on cross-functional and/ or cross-divisional basis in relation to the designated vendor base.
• Provision of in-depth technical / quality expertise re; identification of trends and/or potential compliance gaps and proactively leading the resolution of long-standing or significant issues affecting quality and efficiency.
• Where appropriate, coaching, mentoring and developing team members supporting their personal development and also colleagues in areas of expertise

Skills:

Primary skills include but are not limited to:

• Strong scientific/ technical expertise in R&D activities, coupled with the ability to interact with and influence scientific subject matter experts and senior leaders on various product initiatives and issues.
• Strong compliance knowledge and understanding of regulatory agency regulations and requirements and interpretation and application re; GMPs to a R&D environment.
• Possess deep drug development knowledge; demonstrated ability to facilitate training and learning with colleagues and apply knowledge to enhance the drug development process.
• Demonstrated knowledge of continuous improvement methodologies; ability to direct complex cross-functional initiatives.
• Demonstrated leadership, incl. strategy deployment experience, in a pharmaceutical environment.
• Proven track record of delivering tangible benefits from process improvement activities in a pharmaceutical environment.
• Demonstrated experience in quality risk management in the pharmaceutical industry.
• Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills.
• Strong demonstrated skills in communicating (oral and written) effectively with diverse individuals/groups.
• Experienced and strong people manager with proven track record of developing talent.

Education/Experience:

• Bachelor's degree in engineering, Biology, Chemistry, or related field.
• A minimum of 10+ years of relevant experience working within the pharmaceutical industry or advanced Degree with 8+ years relevant experience.
• Experience interacting with regulatory officials and external auditing parties.

Required Skills:

Coaching, Coaching, Compliance Reporting, Detail-Oriented, External Manufacturing, Leadership Theories, Mentoring Staff, Operational Quality, Organizational Talent, People Leadership, Persuasion, Policy Implementation, Process Improvements, Quality Assurance Systems, Quality Compliance, Quality Management, Quality Management Systems (QMS), Quality Metrics, Quality Standards, Situational Leadership, Stakeholder Management, Strategic Objectives, Supplier Auditing, Task Allocation, Team Collaboration {+ 2 more}

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.

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

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 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

$173,200.00 - $272,600.00

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 .

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

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

10/12/2026

*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.

Requisition ID:

R420708