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Sr Quality Assurance Specialist

Location
Lithonia, Georgia
Posted
22 Sep 2022

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Job Description

About the role:

As the Sr. Supplier Quality Associate, Supplier Quality Management, you will drive the execution of the global Supplier Quality and Material Management programs at the Social Circle, GA Takeda site. You will execute qualification, maintenance and monitoring for the plant's suppliers, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability. You will report directly to the Associate Director, Quality Compliance

How you will contribute:

  • Partner with the business and key stakeholders to drive continuous improvement in Quality performance across the plant and the company, to understand priorities and align on expectations.
  • Supporting local cross functional partners and stakeholders in the Plasma Operations on matters about supplier controls, concerns related to Quality System performance, risk-based audit execution, issue escalation, procurement strategy and regulatory compliance issues, resolves and mitigates Supplier Action Reports (SARs) issued to supplier for a nonconforming material.
  • Implement global supplier and material/product management and audit activities for the suppliers assigned locally:
  • Build relationships with the locally assigned suppliers
  • Create and maintain local product / material specifications
  • Solve material related issues in cooperation with impacted production departments or Quality Control and suppliers resp. manufacturers around the globe (Material Deviations, CAPAs)
  • Supplier Qualification and maintenance / Quality Agreements
  • Supplier Audits
  • Evaluation and Execution of Supplier Notification of Changes
  • Manage change controls e.g. due to necessary product/material specification changes
  • Supplier Monitoring
  • Execute the strategic direction and oversight of external auditing and supplier quality and material management to achieve sustained success for regulatory inspections and supply chain product quality
  • Ensure compliance with the global audit and specification policies, guidance, standards, procedures governing Quality Auditing and Supplier Quality
  • Support the coordination with Global Supplier Quality management group and global audit planning / scheduling group to assign lead auditors and co-auditors to perform audits for critical local suppliers
  • Promptly escalate and report all critical audit findings, critical material issues and supplier performance incidents to the appropriate persons
  • Perform external audits
  • Support Due Diligence activities worldwide providing subject matter expertise to ensure decision-making; identify quality related risks to projects and the provision of resolutions
  • Execute the Supplier Qualification and Product/Material Specification program requirements per schedule
  • Provide performance metrics to drive continuous improvement of the programs
  • Manage performance management and risk identification for suppliers and resolution of incidents
  • Ad-hoc participation with Quality Auditing
  • Understanding of relevant regulations ensuring partnerships across the organization
  • Partner with Production departments and Quality Control to support our priorities from a supplier quality perspective
  • Partner with Procurement on Supplier Quality Management processes and individual suppliers
  • Work with external partners and suppliers
  • The complexity of this role relies in the diversity of manufacturing techniques and suppliers, and the connection to the global team and other Takeda sites.

What you bring to Takeda:

  • Bachelor's degree Sciences or Engineering or related field with a minimum 5 years of experience in the biotechnology, biologics, or pharmaceutical industry.
  • Previous experience in pharmaceutical manufacturing and quality operations would be ideal
  • Experience working with regulatory agencies and/or direct interface experience with regulatory agencies during inspections would be ideal
  • Experience of biologics or pharmaceutical manufacturing
  • Understanding of local and global regulations
  • Present important quality concepts to senior representatives, external partners and internal senior leadership teams
  • Competent in Word, Excel (can perform complex functions), PowerPoint and SharePoint
  • Up to 10% travel
  • This role is a rotational and requires a minimum of 3 days/week on site with 2 days/week work remotely.

What Takeda can offer you:

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

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:

  • Must be able to lift, push, pull and carry up to 15 lbs.
  • In general, you will have a combination of sedentary work and walking around observing conditions in the facility.
  • Will work in controlled environments requiring special gowning, as necessary. Will follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
  • Will work in a cold, wet environment, as needed.
  • Some Clean Room and cool/hot storage conditions.

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.

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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
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Details

  • Job Reference: 718728511-2
  • Date Posted: 22 September 2022
  • Recruiter: Takeda Pharmaceutical
  • Location: Lithonia, Georgia
  • Salary: On Application