Associate Director, Quality Assurance - Change Control

Job Description

Position Description

Associate Director, Quality Management System Change Control will work with the Change Control core team team, Sites, Functional Groups and Additional Stakeholders to sustain, make continuous improvements to Change Control QMS (People, Process, System).  The person in this position has experience in good manufacturing practices within the pharmaceutical industry including change control experience.  The person will provide support to the change control quality system codifed in our Company ck Quality Manual, monitor the performance of the quality system and drive continuous improvement efforts.  The person will monitor site adherence to the company’s codified change control quality system, champion standard work across all sites, and assist sites in the troubleshooting change control issues.  The person will lead a Community of Practice, develop and maintain global training materials, and be a subject matter expert on information systems supporting change control.

Primary activities include, but are not limited to:

• Monitor health authority regulations and ensure that relevant regulations are incorporated into the change control Quality Management System documents.

• Author and maintain global change control topic documents. 

• Ensure procedures are aligned with other Quality Management System topics and functionality updates to the IT platforms supporting the change control process

• Support development and deployment of new and/or enhancement of existing Change

• Management processes and systems

• Interact with Batch Disposition personnel, clinical, Integrated Product Data team and Regulatory scientists to drive further integration of these processes with change control

• Develop and maintain global training materials and deliver training to our Manufacturing Division personnel, as needed.

• Lead a community of practice for Change Control and manage the content of information placed on the CoP’s website.

• Network with functional groups performing change control to provide subject matter expertise, provide direction, and implement best practices and standards.

• Troubleshoot network change control issues and provide guidance on resolution.

• Interface with Information Technology group to identify system improvements that enhance the efficiency and effectiveness of the change control  process.

• Is able to travel ~ 20% of the time to support the change control process at our Manufacturing Division global site network

This position represents an exciting opportunity for a strong leader to make meaningful contributions to the sustainment of a more efficient and effective change control process.  A robust and sustainable change management process is critical to ensure compliance with regulatory dossiers and compliant supply.  The selected candidate will work will stakeholders across the globe and become an integral part of our Manufacturing Division journey.

Education Minimum Requirement:

• Bachelors degree in Science or Engineering; Master’s degree or MBA are preferred.

Required Experience and Skills:    

• B.Sc. in a relevant field of science or engineering, and a minimum 5 years in pharmaceutical and/or vaccine manufacturing environment

Required Experience and Skills:

• Must have experience with Change Control and the IT systems enabling change control (Ex.: Veeva, IPI, Trackwise).

• A continuous improvement mindset and bias to action is important for this role.

Preferred Experience and Skills:

• Background in US and international GMP policy and regulations

• Demonstrated personnel management/leadership skills

• Demonstrated project management/leadership skills

• Strong communication skills

• Working knowledge in Quality Risk Management tools and principles

• Working knowledge of SAP or other relevant ERP system(s).

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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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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