Job Information
Merck Director, QMS Topic Owner – Change Control in Durham, North Carolina
Job Description
The Director, QMS Topic Owner role is critical in our company's effort to create and sustain a simplified, integrated, user-centric global Change Management Process for our human health products, with an objective to enable consistently compliant product quality, continuous improvement, and effective life-cycle management.
The Director is responsible for providing leadership and direction for the development of processes, procedures, and corresponding controlled documentation and systems, within global Quality Management System (QMS) Chapter 3 – Quality Systems & Compliance, as well as local SOP’s and related documents governing Change Control. This role is also responsible for defining the roles and responsibilities for contributing functions to Change Control, ensuring appropriate governance is in place to oversee development, approval, and maintenance of quality standards and global procedures, and creating supporting documents to maintain an effective and compliant Change Control System.
The Director is also responsible for ensuring the end-to-end life cycle process for Change Control 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 content for Change Control, and interface with other chapters/topics, and stakeholders across the network as required.
Work with partners, stakeholders, 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 processes and procedures as they relate to lifecycle management of global and site Change Control.
Provide leadership and technical direction on regulatory requirements for the above in the GMP/GDP environment.
Monitor global regulations with impact on Change Control 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 procedure execution in digital platforms.
Drive the development, implementation, and realization of permanent inspection readiness for Change Control.
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 Required and Experience:
- Bachelor’s degree in Life Sciences, Engineering, or related discipline with ten (10) years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably at a manufacturing site in leading manufacturing and/or quality roles and/or in Global Quality; experience in vaccines, biologics, devices, and API regulations preferred.
Required Experience and Skills:
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 external insights and information.
Capable of working and communicating effectively with all levels of the organization globally.
Proven ability to effectively initiate and drive change across the network.
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.
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.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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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, generally Tuesday, Wednesday and either Monday or 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”.
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:
25%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
06/4/2024
*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: 06/04/2024
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: R295467
Merck
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