Global Quality Shared Services and Regulatory Intelligence Associate Director
Our 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.
Summary, Focus and Purpose
The Global Quality Shared Services and Regulatory Intelligence Associate Director Team is responsible for supporting the progress of our Manufacturing Division level quality programs, initiatives and novel projects. The successful candidate will support the execution of critical programs by providing project management support, monitoring and enabling change execution activities, and partnering with experts/leaders across our Manufacturing Division to conduct gap assessments and drive implementation. You must approach the role with an agile and nimble mindset in order to manage different cross-functional projects across our Manufacturing Division.
Support the management of division-level project portfolio and collaborate with business leaders and project leaders to prioritize, support, and deliver project outcomes.
Develop and implement business intelligence tools and analytics platforms with our Company Manufacturing Division digital to drive results and provide project outputs
the development, communication and execution of project plans in support of division-level projects
Ensure timely and effective upward communication (our Manufacturing Division's leadership (MLT)) and downward communication (e.g., MLT Chiefs of Staff, Regional Leads, global sites, functions, work streams)
Collaborate with the Strategic Operations Team to analyze data and provide holistic, end-to- end coordinated assessments, targeting the audience with the necessary level of detail
Provide project management expertise to project leaders, functions and sites
Develop and coordinate execution of projects with ruthless standardization across our Manufacturing Division network
Monitor and measure current and/or new data to ensure expected outcomes as well as control performance
Establish and maintain strong working relationship with Operating Unit leadership and site leadership
Manage business processes built to integrate regulatory intelligence into our Company’s Quality Management System
Help develop and implement a sustainable process for proactively identifying emerging regulations and evaluating potential impact, as well as defining areas for position formulation and advocacy across our Manufacturing Division
Plan and lead benchmarking with industry best practices
Support activities related to the simplification and standardization of transactional activities across the organization
BA/BS Required (Hard Sciences, Engineering, Business, Project Management or Supply Chain Management)
Eight years in the pharmaceutical industry or related field
Experience in Regulatory Quality compliance
Graduate degree in Business, Science, or Engineering
Small molecule and/or Biologics manufacturing experience
Our 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 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.
Residents of Colorado
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For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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We 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 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.
Flexible Work Arrangements:Remote Work
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Number of Openings:1