Associate Director, Quality Assurance - Hybrid

Job Description

The Associate Director, Large Molecule (LM) Development and Commercialization Team (DCT) Quality Support role will reside within our Research & Development Division Global Development Quality Operations (GDQ Ops) organization. This role is a unique opportunity to demonstrate/develop diverse skillsets in providing strategic and tactical support to the LM DCT QL CoE Center of Excellence, as well as the broader GDQ Quality Operations organization in the following areas:

• Support the LM DCT CoE Quality Leader (QL) in defining and delivering on priorities for the continued evolution of the LM DCT CoE model (i.e. building infrastructure for QL training and onboarding, building standard tools and templates to streamline work, resource forecasting, early program quality support/monitoring, community meeting planning etc.).

• Act as the LM DCT QL/GDQ Point of Contact for specific assigned LM pipeline programs. The DCT QL will lead a program-specific quality working group and provide key quality support on the DCT core team and facilitating the transition of the Quality Lead role to our Manufacturing Division

• Develop and utilize core quality competencies to provide agile support across other areas of GDQ and to contribute to key strategic initiatives spanning our Research & Development Division and our Manufacturing Division.

Primary Responsibilities:

Support Role:

• Provides support to the CoE Quality Leader to evolve and maintain the Quality Lead (QL) CoE which is composed of QLs representatives from various Quality functional groups. 

• Provides support to the CoE Quality Leader for planning and executing the DCT QL Community of Practice meetings, providing a forum for support, leveraging best practices/experiences and sharing of lessons learned between QLs.  Establishes program agendas, meeting notes and providing speakers to further enhance the education of the QLs.

• Help develop standards for tracking of program support, training/on-boarding materials and organizes project resources to ensure these are managed efficiently.

• Helps to work with the QLs to establish Quality networks, appropriate for each program.

• Helps to develop and maintain business process tools, including the DCT QL handbook and PAI readiness tools to assist QLs.  Adapts the tools and business processes to evolving program and portfolio needs (e.g. new modalities, collaborations, evolving quality expectations).

• Help to develop a portfolio view of quality strategies, issues, and plans across programs to ensure leveraging learnings and continuous improvement or coordinated resolution of issues impacting multiple programs.

Role:

• Act as the centralized core expert for quality guidance on assigned LM development programs within the DCT, ensuring compliance with regulatory standards and internal quality policies.

• Provide one voice from across the development quality functional areas to ensure robust quality strategy achieving key program milestones as defined by the DCT Lead.

• Lead a program specific quality working group (QWG) to help ensure robust end to end quality strategy development and serve as core team member for quality support on the program DCT core team.

• Liaise with various quality partners to proactively identify, mitigate or escalate quality related risks.  As well as track quality actions, issues and decisions made with in the QWG for the program.  Promote effective communication and issues escalation of quality related items throughout the development process

• Collaborate closely with our Manufacturing Division quality counterparts, where necessary, for forward looking to line of site to validation and launch milestones to ensure a seamless transition from development to commercial supply.

• Ensure appropriate quality support to enable on time and compliant delivery of clinical supplies throughout program lifecycle and ensure forward looking for expansion of team to enable on time inclusion of our Manufacturing Division quality partners at appropriate time point in program lifecycle.

• Provide quality approval of key phase appropriate deliverables (i.e.. clinical phase specifications, product shipping and handling reports etc.)

• Support regulatory filing and agency engagements for the program, as needed; Serve as GDQ PoC to support any inspection readiness items where appropriate

• Serve as the single point of contact for all DCT quality-related issues, providing expert guidance and oversight

General Quality Support Role:

• Develop and utilize core quality competencies to provide agile support across other areas of GDQ and to contribute to key strategic initiatives spanning our Research & Development Division and our Manufacturing Division.

Education Minimum Requirements:

• BS degree required, with concentration in Science or Engineering (e.g., chemical, biochemical or mechanical engineering, pharmacy/pharmaceutics, chemistry, biology).  Advanced degree preferred.

Required Experience and Skills:

• Minimum 10 years applied professional work experience in one of the following areas: GMP manufacturing, operations, quality organization, analytical, supply chain, technical operations, or process research/development. 

• Strong compliance knowledge and understanding of health authority regulations, and interpretation and application of GMPs (i.e., apply the GMP Continuum).

• Strong interpersonal skills including verbal and written communications, collaboration, teamwork within and across functions, conflict resolution.  Proven ability to work effectively with diverse teams and individuals.

• In depth understanding of the large molecule commercialization lifecycle

• Excellent communication and interpersonal skills, with the ability to work collaboratively across teams and functions.

• Demonstrated leadership ability in managing cross-functional teams and driving project completion to meet deliverables and timelines.

• Strong problem-solving skills and the capacity to navigate complex issues effectively.

Preferred Experience and Skills:

• Prior experience in a Quality organization or Quality-facing role in a development or production department is preferred.

• Direct exposure to or prior experience in interfacing with large molecule development commercialization teams (DCT)

• Direct exposure to the product and supply chain development processes for large molecule and vaccine products in preferred.

• Strong project management skills and wiliness to experiment with potential digital tools to drive efficiency and new ways of working (Power BI, Loop, CoPilot, GPTeal etc.)

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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 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

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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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