Job Information
Merck Director, QMS Quality & Compliance in West Point, Pennsylvania
Job Description
This position is critical our company's effort to sustain a simplified, integrated, user-centric global Quality Management System (QMS) for our human health products, with an objective to enable consistently compliant product quality, continuous improvement, and effective life-cycle management.
The Director, Quality Management Systems, is responsible for providing leadership and direction for the development and sustainment of processes, procedures and corresponding controlled documentation and systems within QMS Chapter 1 – QMS Structure and Lifecycle Management of global QMS and local SOP’s and related documents. This chapter also establishes the requirements, process and defines the roles and responsibilities to ensure there is an appropriate governance in place to oversee the development, approval, and maintenance of quality standards, global procedures and supporting documents to maintain an effective Quality Management System in place.
The 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:
Lead the design, development and implementation of the assigned topic area within the Quality Systems and Compliance chapter. Define the strategy for global requirements and procedures to drive harmonization of processes and systems across the network.
Lead cross-functional global teams developing or improving content for the chapter topics, 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 as it relates to Lifecycle management of global and site/functional QMS documents and related processes.
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 topic content development and or improvements, and ensure all targets are met on time in alignment with quality expectations
As business owner, actively participate in the identification, test and approvals of IT solutions that enable procedures execution in digital platforms.
Drive the development, implementation and realization of permanent inspection readiness for assigned topics.
Actively participate in pharmaceutical industry meetings / regulatory symposia etc., to establish industry relationships, leverage industry best practices and benchmarking, stay abreast of regulatory trends, and implement action plans to proactively address potential GMP compliance impact.
Minimum Education Requirement and Experience:
- Bachelor’s degree in life sciences, engineering, or related relevant discipline with ten (10) years’ experience in the FDA and/or EU regulated pharmaceutical environment.
Required Skills and Experience:
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 defined in ICH Q 10 for Pharmaceutical Quality Systems.
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 the division
Capable of facilitating global forums and maintaining effective Communities of Practice, Common Interest Groups, and other Knowledge Management solutions.
Experienced with data analytics, development, and use of visualization tools to convey performance messaging.
Preferred Skills and Experience:
Experience 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.
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.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
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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”.
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:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
10/7/2024
*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.
Job Posting End Date: 10/07/2024
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.
Requisition ID: R315909
Merck
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