Merck Associate Director, Clinical Release in Kenilworth, New Jersey
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.
This position reports to the Director, Clinical Release and is critical to maintaining the clinical supply chain via the oversight of disposition activities of investigational medicinal product at our External Contract Manufacturers. Specifically, this includes oversight for ensuring our clinical supplies are in compliance with current Good Manufacturing Practices and relevant regulatory submissions via direct support for batch release and directing team-based process assessments and enhancements.
Areas of focus of this position revolve around the detailed workings of clinical packaging and labelling activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex / niche supply chains and supply types to support aspects such as Managed Access Programs, Joint Ventures / Collaborations, Independent Investigator-Initiated Studies etc. in addition to standard clinical protocols.
This role will also assist in managing when necessary significant quality events such as formal Quarantine and Recovery actions that require rapid and effective liaison with many internal and external stakeholders, including at senior levels.
Primary activities include but are not limited to:
Evaluation and/or disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations.
Closely partner with appropriate business/operations areas to ensure that effective and robust Quality systems and processes are in place.
Coordinate and provide guidance in the preparation of procedures, processes and quality improvements where warranted.
Coordinate significant quality events including fact finding, investigation, coordination of clinical quarantine and recovery actions.
Position Qualifications :
Education Minimum Requirement:
Bachelor’s Degree in Science (Biology, Chemistry or any related fields)
At least 8 year’s experience in the Pharmaceutical or equivalent industry.
Strong comprehension of regulatory agency regulations and requirements coupled with proficiency in interpreting and applying current Good Manufacturing Practices (cGMPs) to our Research & Development environment.
Computer skills; knowledge and competency in SAP/MES, Trackwise, PowerPoint, Excel and Word.
Ability to manage multiple priorities and projects.
Comprehensive Lean Six Sigma and Project Management skills; ability to lead matrix teams, recognize improvement opportunities, develop appropriate solutions and follow through on implementation.
Strongly developed cross-functional teamwork, partnership, influencing and negotiating skills.
Ability to lead teams of a cross-functional and multi-level nature, including senior management representatives.
Excellent verbal and written communication and presentation skills.
Our Manufacturing & Supply Division is dedicated to be the most trusted supplier of bio-pharmaceuticals 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., 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 …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
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.
US and Puerto Rico Residents Only:
If you need an accommodation for the application process please email us at firstname.lastname@example.org
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEOC GINA Supplement at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocgina_supplement.pdf
OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf
We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
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.
Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
Requisition ID: R84379
- Merck Jobs