Skip to main content

Search Our Jobs

SR Quality Compliance Specialist

Social Circle, Georgia


Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

Back to Job Navigation (Overview)


What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

Back to Job Navigation (Success)

Back to Job Navigation (Life at Takeda)


  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2021.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

Back to Job Navigation (Rewards)

SR Quality Compliance Specialist

Apply Now
Job ID R0033642 Date posted 04/20/2021 Location Social Circle, Georgia

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’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Responsible for executing the various quality systems and business practices which enable positive outcomes of Health Authority (HA) inspections, as well as other external and internal audits.  Responsible for the ownership and/or execution of the various processes and systems related to the Quality Compliance function at the Covington Manufacturing Facility including, but not limited to: inspection readiness,  inspection management, product complaint management, risk management, and quality incident escalations.  The role will entail identifying and implementing continuous improvement initiatives related to the site’s Quality Systems.

This position will serve as either a ready room coordinator, inspection liaison, and/or inspection host during inspections. The role will include being an independent internal auditor to perform site self inspections. This position is also responsible for leading various projects internal and/or external to the department.  The level is also responsible for collaborating within the network to share inspection knowledge and drive process improvements at the site and global level.  This level is expected to demonstrate skills as a subject matter expert during internal and external inspections. 

Responsible for maintaining the site compliance program including GMP/Compliance walkthroughs, gap assessments, and delivery of continued education on GMP and Compliance; the handling of product complaints including timely closure of associated records; and the preparation and maintenance of key quality indicators and site metrics for the appropriate communication to Site Leadership and Global teams.

Supervision and guidance are mainly required to clarify directions; this level is capable of determining their own priorities and working with area and senior management to eliminate roadblocks.

Job Function and Description

  • Interface with manufacturing, quality, and other support groups to promote adherence as well as resolve issues related to GMP and Compliance.  Provide innovative solutions and drive continuous improvement initiatives related to various site processes.
  • Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements.
  • Lead and/or facilitate the observation response process as per applicable procedures and to ensure the prevention of repeat observations. 
  • Lead “Audit Ready – All the Time” efforts for assigned areas and assist other areas within the facility in understanding FDA, EMA, ISO, and other quality requirements.
  • Lead and/or conduct GMP/Compliance walkthroughs to identify potential gaps or risks and provide guidance on mitigation/resolution.
  • Maintain inspection readiness plan; conduct inspection readiness and management training; and coordinate inspection support staff.
  • Monitor ICAMS, QRAMS, and GCMS records for adherence to Global requirements.  Identify potential concerns and recommend when escalation is needed.
  • Lead and/or execute the product complaint handling process including completion of complaint evaluations and associated investigations.
  • Lead and/or facilitate the gap assessment process and maintain the site risk register.
  • Lead and/or actively participate in Quality Systems operating mechanisms at defined frequencies (e.g. Quality Council meeting, KPI meeting, Site Complaint Review meeting, etc.)
  • Compile and/or review various key quality indicator trends/metric data at defined frequencies.  Prepares and reports trend and metric data via management review operating mechanisms.
  • Support activities related to Quality Incident Escalations, and escalation meetings as applicable.
  • Author, assess, and/or approve inspection, complaint, deviation, and change records as needed.
  • Represent the Quality Compliance department in network meetings as applicable.
  • Provide guidance and coaching for areas of responsibility to less experienced individuals within the plant.
  • Complete other tasks as assigned by management
  • Typically requires bachelor's degree in science, engineering, or other related technical field with 5+ years of related experience.
  • Prefer experience with supporting HA inspections, e.g FDA, EMA, other MoHs
  • Prefer experience with Product Complaint Management

  • Strong knowledge of regulatory regulations, cGMP, and Quality Systems is required.
  • Strong problem-solving and analytical skills are required.
  • Possess knowledge of core manufacturing principles and support systems.
  • Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
  • Possess good interpersonal/communication/influencing/negotiation skills.
  • Be a self-driven individual who requires minimal supervision.
  • Possess proficient computer skills and be experienced using MS Office software (Word, Excel, and PowerPoint).
  • Possess good project management skills.
  • Prefer experience with the TrackWise quality system.
  • Prefer knowledge of Lean/Six-Sigma methodology.

Physical Demands:

  • In general, the position requires a combination of sedentary work and walking around observing conditions in the facility
  • Must be able to lift, push, pull and carry up to 20 lbs. In general, the position requires a combination of sedentary work and walking around observing conditions in the facility

Working Environment:

  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body.
  • No make-up, jewelry, nail polish, or artificial fingernails, etc. may be worn in the manufacturing environment.
  • Will work in a cold, wet environment
  • Requires flexibility to complete activities during off shift hours and/or conduct activities in support of different shifts as needed.

This job posting excludes CO applicants.


USA - GA - Social Circle - Hwy 278

Worker Type


Worker Sub-Type


Time Type

Full time

Job ID R0033642
Apply NowEmail Me

Back to Job Navigation (Responsibilities)

Explore the Area

Check out where you could be
working if you apply.

View Map