Merck Organon, Quality Management Systems - Associate Director in Kenilworth, New Jersey
The Quality Management Systems (QMS) Associate Director reports to the QMS Director overseeing QMS chapters 6 (manufacturing), 7 (laboratory systems) and 8 (continued product assessment & reporting) within the Quality Compliance Organization as part of our company's Manufacturing & Supply (OMS).
Critical to the success of this role is, in alignment with the Quality Compliance organization and key stakeholders is to assist with the execution of the strategy for development and deployment of the OMS Quality Management System as our company stands up as an independent entity to ensure robust compliance is maintained, while also acting as an enabler for the current and future operations of our company.
This position is key in our company's effort to create a simplified, integrated, user-centric global Quality Management System (QMS) for our products, with an objective to enable consistently compliant product quality, continuous improvement and effective life-cycle management. The position, in alignment with the OMS Quality Compliance team and key stakeholders, will help define the strategy for development and deployment of the OMS Quality Management System as our company stands up as an independent entity to ensure robust compliance is maintained, while also acting as an enabler for the current and future operations of our company.
The QMS Associate Director is responsible for the development of processes, procedures and corresponding controlled documentation and systems within topic(s) assigned within the scope of QMS Chapters 6 (Manufacturing), 7 (Laboratory Controls), and 8 (Continued Product Assessment & Reporting).
The QMS Associate Director is also responsible for ensuring the end-to-end life cycle process for the QMS is well defined per the attributes of a quality system, there is a robust management system in place to monitor the process and that any gaps are identified and managed to completion.
Processes are defined with adequate Procedures, Governance, and clear Roles, Responsibilities and Accountabilities
The Organization and Infrastructure to support the execution of the processes are defined and installed
Metrics are developed for the ongoing evaluation that the system is working as intended, reviewed by the appropriate levels of management, and used as a basis for continual improvement
Primary activities include, but are not limited to:
Responsible for obtaining input into the design and development as well as implementation of the OMS QMS deployment strategy related to assigned topics within chapters 6, 7, and 8.
Lead cross-functional global teams developing content for the chapter, and interface with other chapters/topics, and stakeholders across the network as required.
Work with (sub-) topic owners and subject matter experts to assess system performance and drive continual improvement.
Ensure quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company’s QMS Provide leadership and technical direction on regulatory requirements for the above in the GMP/GDP environment.
Monitor global regulations with impact on assigned topics to develop and sustain accurate interpretation of regulatory requirements per market, in alignment with QMS policies and procedures.
Help identify, resolve/mitigate or appropriately escalate any issues or delays in content development project execution, and ensure all targets are met on time, in full and to quality.
Drive the development, implementation and realization of permanent inspection readiness for assigned topics.
- Bachelor's Degree in science, engineering, or related areas of study.
Required Experience and Skills:
Minimum of 8 years experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in leading manufacturing and/or quality roles and/or in Global Quality; experience in vaccines, biologics, devices and API regulations preferred.
Demonstrated leadership in Quality & Compliance discipline and in-depth knowledge of global health authority regulations and requirements, with the ability to effectively translate and communicate these requirements.
Subject matter expertise in regulatory requirements and expectations for manufacturing, laboratory controls or continued product assessment & reporting
Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites & functions.
Excellent facilitation and project management skills, with strong verbal and written communication skills.
Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management.
Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.
Demonstrated ability to make and act on decisions while balancing speed, quality and risk.
Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
Capable of working and communicating effectively with all levels of the organization globally.
Proven ability to effectively initiate and drive change across a diverse and multi-functional organization
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
US and Puerto Rico Residents Only:
If you need an accommodation for the application process please email us at [email protected]
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
EEOC GINA Supplement (https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocgina_supplement.pdf)
OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf)
OFCCP Pay Transparency Rule (https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf)
We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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.
Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
Requisition ID: R85125
- Merck Jobs