New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
Our Supply Chain team ensures inventory is consistently available to meet customer demand. We coordinate all aspects of supply through supply planning, sourcing, making, inventory management, packaging and delivery. We partner across the Marketing, Finance and Manufacturing organizations to build a robust demand and supply plan and ensure we get products to the right customer, at the place, at the right time.
Associate Director, Change Control Engineer
The Associate Director (AD) Change Control Engineer is a team leader that motivates professionals to exceed business objectives by leveraging the strengths of the individuals on the team and capitalizing on their potential. Through mentoring, modeling, and providing executional oversight the AD confidently leads the Change Control Engineer team to meet and/or exceed agreed upon goals that ultimately benefit customers and patients. Recognized as the subject matter expert in Change Control functions making decisions based on policies, procedures, requirements, and guidelines.
Primary Duties include, but are not limited to:
Provides project management leadership for the largest, most complex, high-priority, high-visibility launches with significant above-site/off-site involvement
Responsible for planning, assigning, and directing work for team members
Answers team member questions, helps with team member problems, and oversees team member workload
Provides subject matter expert guidance to other functions at Wilson as well as to mentors team members and other functions
Authorized to develop policy in conjunction with Associate Director, Wilson Engineering Services on internal processes
Manages the site change control QMS system including periodic system reviews, monthly metric reporting and training.
Sets compliance direction for the site for change control by ensuring adherence to divisional policies and guidelines as well as regulatory requirements. Ensures new and updated divisional policies, guidelines and procedures are reviewed for alignment to site procedures.
Coordinates Change Review Board meetings for the site and ensures alignment with above site requirements and reports monthly metrics. Responsible for the development and issuance of pre-meeting and post-meeting deliverables (i.e., agenda, meeting minutes, actions, communications, etc.)
Secondary Duties include, but are not limited to:
Develops team members skills to enhance contribution to the organization and preparing them for advancement
Assesses skills of all team members while developing and maintaining annual training plans/matrix
Collaborates with Functional CoEs, stakeholders and customers to achieve business outcomes
May be responsible for management of up to several contract resources and be able to define goals and direct their time effectively toward attaining goals
Serves as grantee of authority for Associate Director, Wilson Engineering Services in that person's absence
Succession planning for key roles in the organization
Education Minimum Requirement:
Required Experience and Skills:
7 years of project management experience with the ability to multi-task
7 years of relevant work experience
Extremely detailed in both technical writing and verbal communications/documentation
Must be able to organize and manage multiple projects that span different timelines
Risk-based decision making skills without knowledge of all the inputs
Positive attitude, strong work ethic, ability to work under pressure, and be a fast learner
Must be able to work in a Team-environment and collaborate cross-functionally
Strong Microsoft Office Knowledge – especially Outlook, Excel, and Word
Preferred Experience and Skills:
Project Management Professional Certification
Microsoft Project experience
Experience with GCM TrackWise and SAP
Working knowledge of our Company policies & procedures, environmental, safety standards and guidelines, GMP's, governmental regulations (e.g. OSHA), industry and engineering standards
Working knowledge of Materials Requirements Planning System (SAP) and interrelationship with the Planning and Scheduling functions
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals 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.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, 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.
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:
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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.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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
Travel Requirements:No Travel Required
Flexible Work Arrangements:Flex Time, Remote Work
Shift:1st - Day
Valid Driving License:
Number of Openings: 1