By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

About the role:

The Manufacturing Supervisor, GMP Program Owner position is responsible for design, maintenance and oversight of the manufacturing-owned GMP programs that are common between the manufacturing buildings at the Covington site. You will ensure that manufacturing GMP programs are compliant to current regulatory standards and are performed by manufacturing staff. The manufacturing-owned GMP programs that fall within scope include: GMP cleaning (initial focus of the position), gowning, material ingress and, to classified area (DCA) programs.

How you will contribute:

• Support and emphasize the Safety and Quality commitments of the department. Make decisions concerning these commitments within the area.
• Problem resolution (floor residue, how to clean hard to reach areas)
• Feedback to ISS / IFMME
• Ownership of the Manufacturing-owned GMP programs, documents, and business processes.
• Audit presentation, drafting of audit responses and audit actions
• Cleaning logbook ownership (issuance, daily review, reconciliation)
• Onboard new GMP materials/disinfectants to support manufacturing-owned GMP programs
• Provide a positive and equitable working environment emphasizing respect, responsiveness and results.
• Assess adequacy of training for applicable tasks and facilitate training when needed
• Self-identification of program improvements
• Design / creation of job aids, SOPs, work instructions, risk assessments.
• Address program escalations
• Escalation and management of program execution gaps
• Periodic review and gap assessment for applicable documents.
• Align program requirements (Global, GMP, continuous improvement)
• Commit to employee feedback and developmental process – support Talent Management goals, conduct recognition and disciplinary action for employees, facilitate employee representation throughout the organization.

What you bring to Takeda:

• Manage multiple groups.
• Writing and ability to prepare technical documents.
• Work with all levels of personnel to resolve issues related to manufacturing, Quality, documentation, and personnel issues.
• Collect and analyze data to determine paths for process improvement and potential cause/corrective actions in the case of exceptions.
• Assessment and troubleshooting skills.
• Manage various processes in a manufacturing plant setting.
• Demonstrate interpersonal and leadership skills with the ability to work with well with other departments, and lead in a team environment.
• Experience with GMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
• Work in and facilitate a team-oriented environment.
• Typically requires Bachelor's degree preferred in Science, Engineering or other related technical field. 3+ years of related experience with 1+ years in a supervisor role.
• Respond to detailed inquiries, and present information to groups and senior management.

What Takeda can offer you:

• Family Planning Support
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Comprehensive Healthcare: Medical, Dental, and Vision
• Tuition reimbursement
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Professional training and development opportunities

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a cold, wet environment.
• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• May require immunization before performing work within the manufacturing area.
• Will carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
• Will require bending, twisting, reaching overhead, and squatting motions to perform certain tasks.
• Work multiple shifts, including weekends, or be asked to work supplemental hours.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• Will climb ladders and stairs while wearing special gowning.
• Will stand for extended periods of time over an entire 8 or 12-hour shift.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

#GMSGQ

#ZR1

#LI-MA1

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time