Director, Quality Assurance Hybrid

Job Description

The Director Quality Assurance will be responsible for team leadership and technical subject matter expertise in Sterile Drug Product Quality Operations at our Companys Rahway New Jersey site. This position will serve a critical role in supporting the expansion of clinical development activities at the site with responsibilities including but limited to the following:

• Execute GMP quality assurance activities directly related to sterile drug product production and release for clinical trial material supply.

• Support the start-up of a new state-of-the-art sterile filling line.

• Support the design and operational readiness of multiple other significant capital projects that are aligned with the expanding site mission.

• Develop relationships with and provide Quality oversight of key partner groups that are commensurately expanding in size and scope of work.

• Lead and develop a growing team of professionals.

The successful candidate will assure that quality systems and controls for investigational new drugs (investigational medicinal products) meet all quality requirements regulatory standards and meet continuous clinical supply and delivery expectations.

Essential Duties and Responsibilities:

• Lead and perform quality assurance activities (e.g. review and approve GMP documentation) related to internally and externally sourced sterile drug products in a complex and rapidly changing clinical development environment.

• Support sterile drug product manufacturing in compliance with cGMP regulatory expectations and clinical filings.

• Provide Quality oversight of formulation process and analytical development activities

• Provide Quality oversight of investigations of events or deviations to support batch release and facility control decisions.

• Enable ongoing start-up of a new state-of-the-art sterile filling line.

• Support evaluation introduction and installation of new processes technologies and capabilities.

• Support design and operational readiness of sterile manufacturing facility expansion.

• Build effective collaborative working relationships and create effective communications within and across organizations and with all stakeholder functions and levels.

• Identify improvement/efficiency opportunities and propose and implement appropriate solutions.

• Provide a Quality mindset while balancing operational needs to develop pragmatic solutions to complex technical and compliance challenges.

• Support activities necessary to achieve GMP compliant and continuous clinical supply.

• Serve as steward for knowledge management and capability build within team.

• Manage program assignments and facility coverage.

Education Minimum Requirement:

• Bachelors degree in science engineering or related discipline; an advanced degree will be preferred.

Required Experience Knowledge and Skills:

• Minimum of 12 years of experience in Pharmaceutical / Biotechnology industry role(s).

• Experience in Quality and manufacturing operations of sterile drug products at pilot and/or commercial scale.

• Strong knowledge and application of Current Good Manufacturing Practice (cGMP) for sterile product manufacturing (e.g. Annex 1) and the application of Quality Risk Management principles.

• Technical understanding and knowledge of manufacturing processes and unit operations for sterile and/or large molecule products.

• Leadership of cross-functional teams investigations or problem-solving situations.

• Interpersonal skills in verbal and written communications collaboration teamwork negotiation and conflict resolution.

Preferred Experience and Skills:

• A combination of experiences in sterile product formulation development process development manufacturing technology transfer scale-up facilities quality systems and / or quality operations

• Advanced technical knowledge in one or more elements of sterile products processing sterile dosage forms and associated technologies.

• Advanced ability to identify and solve complex problems in a timely and efficient manner.

• Experience in R&D or clinical supply areas and processes

• Experience with leading growing and developing teams

• Experience with facility design and start-up

EligibleforERP

Required Skills:

Preferred Skills:

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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 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 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.

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