Job Description
This position reports to the Associate Director, Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc.
Responsibilities May Include, But Are Not Limited To:
- Evaluation and 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.
- Coordinate and/or support the preparation of procedures, processes and quality improvements.
- Assists in the coordination of significant quality events including fact finding, investigation, coordination of clinical quarantine and recovery actions.
- Collaboration across cross-functional and business areas to ensure robust processing, continuous improvement and cross-functional team building.
- Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve outcomes, reduce cost, or lower our processing cycle times.
- Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.
- Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System (PS) tools, both in problem-solving and day-to-day operational activities.
Education:
- Bachelor's degree with a technical emphasis in an appropriate scientific or engineering field.
Required Experience And Skills:
- Minimum of 5 years experience in the pharmaceutical or equivalent industry Good Manufacturing Practice (GMP) related field including Technical, Engineering, Quality or Operations.
- Familiarity with batch disposition (release) activities.
- Background in quality control, quality assurance, auditing or regulatory affairs.
- Effectiveness and creativity in approaching and solving technical problems.
- In-depth working knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
- Basic understanding of the use and maintenance for Microsoft applications (such as Excel, Outlook, Access).
- Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
- Demonstrated teamwork skills.
- Attention to detail, flexibility and an awareness of production and quality control problems.
Preferred Skills:
- Ability to independently manage multiple priorities and projects.
- Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives.
- Demonstrated analytical and problem-solving skills.
- Knowledge of Lean Six Sigma and Project Management.
- Knowledge and competency in ERP/MES, Trackwise, SAP, PowerPoint, Excel and Word.
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.
As An Equal Employment Opportunity Employer, We Provide Equal Opportunities To All Employees And Applicants For Employment And Prohibit Discrimination On The Basis Of Race, Color, Age, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Protected Veteran Status, Disability Status, Or Other Applicable Legally Protected Characteristics. As a Federal Contractor, We Comply With All Affirmative Action Requirements For Protected Veterans And Individuals With Disabilities. For More Information About Personal Rights Under The U.S. Equal Opportunity Employment Laws, Visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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):
No
Required Skills:
Adaptability, Adaptability, Audits Compliance, Business, Clinical Protocol, Clinical Testing, Communication, Continual Improvement Process, Cross-Functional Teamwork, Data Analysis, Detail-Oriented, Deviation Management, Employee Training Programs, GMP Auditing, GMP Compliance, Interpersonal Relationships, Investigation Management, Lean Management, Lean Six Sigma (LSS), Management Process, Manufacturing Processes, Manufacturing Quality Control, Medical Risk Management, Medical Supply Management, Microsoft Applications {+ 18 more}
Preferred Skills:
Job Posting End Date:
05/19/2025
- A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R348708
