Director, Quality Management Systems
Company: Merck & Co., Inc.
Location: Wilson
Posted on: May 18, 2023
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Job Description:
Job DescriptionOur Quality Assurance group ensures every single
material inside our products is manufactured, processed, tested,
packaged, stored and distributed aligned with our incredibly high
standards of quality and meets all regulatory requirements.
Partnering across our internal manufacturing facilities, external
contract manufacturers and suppliers we create an interdependent
global manufacturing network dedicated to deliver a compliant,
reliable supply to customers and patients on time, every time,
across the globe.We are seeking a Growth and Improvement minded
Quality Management Systems Director that can help drive our
Strategic Operating Priorities.* Invent - Pursue the Most Promising
Internal and External Science to Address Significant Unmet Medical
Needs* Execute - Prioritize Resources Behind Our Key Growth Drivers
(Oncology, Vaccines, Select Specialty Areas, Animal Health) While
Optimizing Our Base Business)* Adapt - Develop Our People, Culture
and Business Model to Evolve with a Dynamic Landscape* Diverse
Talent - We are committed to providing an inclusive and welcoming
environment with supporting leadership behaviors because having a
high-performing, engaged workforce is critical to our ability to
deliver innovative solutions to patients and customers around the
world* Values and Standards - Our Steadfast Commitment to Our
Values and Standards will Continue to Guide Us as We Take on New
Challenges and Will Always be Fundamental to Our Success - They are
a Competitive Advantage for UsStrategic Summarythe Quality
Management Systems Director will drive a critical effort to create
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 Quality
Management Systems Director for the Training and Qualification
topic, is responsible for providing leadership and direction for
the development and life cycle management of processes, procedures,
systems, and corresponding controlled documentation (as specified
within QMS Chapter 1 - Quality Management Systems Operations)
related to the Training and Qualification topic. The successful
candidate will ensure their QMS is well defined per industry
standards, there is a robust management system in place to monitor
the health of the Training and Qualification system, and that any
gaps are identified and managed to closure, specifically:*
Processes are defined with adequate Procedures, Governance, and
clear Roles, Responsibilities and Accountabilities* 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
improvementKey Functions* Work independently and as a Team member
with Integrity - Precision - Accomplishment - Motivational Ambition
- Respect - Inclusion* Identify the regulatory requirements and
define the strategy for global procedures for their topic and drive
harmonization of processes and systems across the network* Lead
cross-functional teams in the design, development, and
implementation of their topic within the Quality Systems and
Compliance chapter (QMS Chapter 3)* Interface with other QMS
Chapter and Topic Owners to ensure seamless linkages with their
systems, as required, and provide ample opportunities and forums to
interact with relevant user communities and stakeholders* 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 their topic* Provide leadership and technical
direction on regulatory requirements for the above in the GMP/GDP
environment* Monitor global regulations of major markets and assess
any impact on their topic in alignment with QMS policies and
procedures* Help identify, resolve/mitigate or appropriately
escalate any issues or delays in topic development, adoption, or
enhancement* Serve as business owner for IT platforms that enable
the execution of their topic by fully participating in the
identification, testing, and approval of IT solutions and
enhancements* Drive the realization of permanent inspection
readiness for their topic across the network* Partner with Global
Learning and Development to ensure their understanding of the topic
requirements in support of their responsibility to develop the
content of any cGMP/cGDP training assets* 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
impactEducation* Bachelor degree in Life Sciences, Engineering or
related relevant disciplineRequired* Ten years'' 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* Demonstrated leadership in Quality &
Compliance discipline and in-depth knowledge of global health
authority regulations and requirements and 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 and functions* Effective
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 and
objectives* Demonstrated ability to make and act on decisions while
balancing speed, quality and risk* 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 Manufacturing Division network* Capable of facilitating
global forums and maintaining effective Communities of Practice,
Common Interest Groups and other Knowledge Management solutions*
Data analytics, development and use of visualization tools to
convey performance messagingPreferred* Vaccines, biologics, devices
and API regulationsOur Manufacturing & Supply Division is dedicated
to being the most trusted supplier of biopharmaceuticals worldwide.
Our facilities, along with our external contractors, suppliers, and
partners, create a reliable global manufacturing network that''s
devoted to delivering a high-quality, reliable supply to customers
and patients on time, every time.Who we are ...We are known as
Merck & Co., Inc., Rahway, New Jersey, USA in the United States and
Canada and MSD everywhere else. For more than a century, we have
been inventing for life, bringing forward medicines and vaccines
for many of the world''s most challenging diseases. Today, our
company continues to be at the forefront of research to deliver
innovative health solutions and advance the prevention and
treatment of diseases that threaten people and animals around the
world.What we look for ...Imagine getting up in the morning for a
job as important as helping to save and improve lives around the
world. Here, you have that opportunity. You can put your empathy,
creativity, digital mastery, or scientific genius to work in
collaboration with a diverse group of colleagues who pursue and
bring hope to countless people who are battling some of the most
challenging diseases of our time. Our team is constantly evolving,
so if you are among the intellectually curious, join us-and start
making your impact today.NOTICE FOR INTERNAL APPLICANTSIn
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.New hires in office-based roles in the US & Puerto Rico
will be required, subject to applicable law, to demonstrate that
they have been fully vaccinated for COVID-19 or qualify for a
medical or religious exemption to this vaccination requirement that
can be accommodated without an undue burden to the operation.
However, subject to applicable law, employees working in roles that
the Company determines require routine collaboration with external
stakeholders, such as employees in health services, customer facing
commercial, or research based roles, will be required to be fully
vaccinated as a condition of employment.Current Employees apply
HERECurrent Contingent Workers apply HEREUS and Puerto Rico
Residents Only:Our company is committed to inclusion, ensuring that
candidates can engage in a hiring process that exhibits their true
capabilities. Please click here if you need an accommodation during
the application or hiring process.For more information about
personal rights under Equal Employment Opportunity, visit:EEOC
PosterEEOC GINA SupplementOFCCP EEO SupplementPay Transparency
NondiscriminationWe are proud to be a company that embraces the
value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas
come together in an inclusive environment. We encourage our
colleagues to respectfully challenge one another''s thinking and
approach problems collectively. We are an equal opportunity
employer, committed to fostering an inclusive and diverse
workplace.Residents of Colorado:Click here to request this role''s
pay range.Search Firm Representatives Please Read CarefullyMerck &
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:RegularRelocation:No relocationVISA Sponsorship:NoTravel
Requirements:10%Flexible Work Arrangements:Flex TimeShift:1st -
DayValid Driving License:Hazardous Material(s):NoNumber of
Openings:1
Keywords: Merck & Co., Inc., Wilson , Director, Quality Management Systems, Executive , Wilson, North Carolina
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