Executive Director, Quality Assurance

Job Description

The Executive Director of Global Clinical Supplies Quality is responsible for providing leadership to a team of Quality professionals assuring the reliable availability, quality and regulatory compliance of clinical supplies in support of the clinical development programs for the R&D portfolio to enable the execution of all clinical trials (including more than 300 Phase I-IV clinical trials run inhouse, 400+ outsourced trials, 200+ IIS clinical trials and 200+ External Collaborations across 60+ countries) in accordance with worldwide regulations, company policies and standard operating procedures. 

The position will be instrumental in developing and utilizing an organization of skilled people managers and technical SMEs in close collaboration and partnership with Global Clinical Supply, Global Clinical Trial Operations, Translational Medicine, Global Regulatory Affairs & Clinical Safety and Quality functions enabling the R&D portfolio. This position will require strong strategic and leadership skills to manage and solve problems for the diverse and fluid requirements of our complex clinical supply chain while also influencing outcomes and continuously improving the systems, tools and processes required to enable to supply chain.

Key areas of responsibility include:

• Quality oversight of clinical supply chain activities (packaging, device assembly, labeling and distribution operations) for the internal network sites including West Point, Rahway, WAG & Haarlem as well as the global external network through leadership of a matrix organization of approximately 165 team members (~85 through direct reporting relationship and ~80 through dotted line reporting relationship). 

• Management of the Global Clinical Complaints process as well as cross-divisional activities for significant quality events impacting the R&D portfolio. 

• Oversight of the enabling functions within Global Development Quality including forecasting and planning, process ownership for business systems and tools and digital innovation for Quality Operations activities. 

• Oversight of the transition and team establishment of the clinical trial country release activities ensuring timely execution in support of the R&D portfolio.

• Develop long-term strategic plans and translate into integrated operational team priorities and activities.

• Ensure measurable and sustainable results through effective resource allocation, cross-divisional partnerships and execution of innovative strategies to enhance the organization's performance.

• Drive a global and harmonized approach to clinical supplies GMP activities and influence strategic plans via networking and partnerships with key stakeholders.

• Inspire and oversee multiple teams, ensuring team leaders are effectively supporting and empowering their teams.

• Management of significant quality events via acting as the facilitator of the Pharmaceutical Quality Council/ Stock Recovery Committee and the owner for the Clinical Stock Quarantine / Recovery process.

• Overall accountability of the ownership and management of the Clinical Complaints process, via the Global Clinical Complaints team.

• Interact cross-functionally and cross-divisionally with senior management on a wide array of topics involving quality/regulatory matters of the most complex and business-critical nature and externally with regulatory inspectors and colleagues in industry.

Education:

• Bachelor Degree in Engineering, Biology, Chemistry or related field.

Required Experience and Skills:

• 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

• Organizational design, development and deployment in relation to dynamic business drivers

• Division-level credibility / influencing ability founded on sound technical knowledge and delivery of results

• Demonstrated leadership, strategy development and deployment experience in a pharmaceutical environment

• Experienced and strong people manager with proven track record of developing talent

• Direct experience in managing significant quality events (e.g. recalls) of a complex and high-profile / potential high-impact nature

• Proven track record of delivering tangible benefits from process improvement activities with a demonstrated knowledge of continuous improvement methodologies; ability to direct complex cross-functional initiatives

• Strong compliance knowledge and understanding of regulatory agency regulations and requirements and interpretation and application re; GMPs to a R&D environment

• Strong scientific/ technical expertise in R&D activities, coupled with the ability to interact with scientific subject matter experts as a technical peer on various product initiatives and issues

• Possess deep clinical supplies process knowledge; demonstrated ability to facilitate training and learning with colleagues and apply knowledge to enhance the clinical supplies process.

• 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

#gracs

#eligibleforerp

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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 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.