Merck & Co Hiring for Senior Specialist, Change Control Process Steward job in Elkton Full Time

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 committed 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 Senior Specialist – Change Control Process Steward 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 Us

Summary, Focus and Purpose

As a member of the Quality department, the Quality Management Process Steward for Change Controls is accountable for the design, implementation, sustainment, and performance of standard business processes specific to this area of Quality Management System.-The role interacts with quality, production, technical operations, and maintenance personnel across the plant site and with other sites and global support groups.- Some of the responsibilities of the Process Steward include:

Key Functions

• Monitor standard work within the QM space and implement improvements to eliminate waste, streamline, provide solutions and prevent problems, and improve effectiveness with regard to change management (GMP and Safety) and relevant quality management systems.- Serve as subject matter expert for change managements systems.
• Gather, analyze and report process performance metrics to ensure continuous improvement.- Assume accountability for process performance – implement and maintain chain management metrics.- Identify and overcome obstacles.- Identify and implement continuous improvement initiatives within the change control program
• Collaborate with other site Process Stewards and regional/global stewards.
• Manage site community of practice and support upskilling of end users
• Serve as Quality Management System (QMS) Sub-system / Topic Owner for quality related sub-systems such Change management ensuring site compliance with Quality Manual requirements.
• Serve as Site Steward for EHS Change Management program.
• Develop and maintain SOPs, process documentation, training, change management and delivery of end user training.
• Engage vertically and horizontally to ensure integrated end to end processes across all value chains.
• Autonomy to make complex decisions and judgment to elevate decisions to regional/global stewards.
• Represent and support the plant site with internal and external audits and inspections.
• Ensure inspection readiness of Change Management program.
• Perform other activities and projects as directed.
• Escalate program issues and risks for alignment with senior leadership.
• May supervise other individuals.

Minimum Education and Experience Requirement

• Bachelor’s Degree of Science (BS) in Engineering or Science or related areas of study with five (5) years pharmaceutical quality assurance, technical or manufacturing/laboratory experience.
• Master’s Degree of Science (MS) in Engineering or Science or related areas of study with three (3) years pharmaceutical quality assurance, technical or manufacturing/laboratory experience.

Required Experience and Skills

• 1 year of experience in the IPI change control platform.
• Experience-balancing workload, prioritizing multiple high priority activities, managing complexity and ambiguity, and delivering results.
• Technical Writing skills.
• Ability to lead small teams and teach others.
• Experience with continuous improvement and how to manage projects.
• Experience using Problem Solving skills to resolve complex issues.

Preferred Experience and Skills

• Strong understanding of Our Company’s Quality Management System
• Understanding of FDA regulations/guidance-
• Ability to manage/prioritize multiple projects and deadlines
• Project management experience
• Change management experience
• Lean Six Sigma

Our Manufacturing & Supply Division is committed to be the most trusted supplier of biopharmaceuticals 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.-

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US 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 Know Your Rights

EEOC GINA Supplement-

Pay Transparency Nondiscrimination

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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

Requisition ID:R247732