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Associate Director, Quality Control

Social Circle, Georgia
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At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.

Job ID R0127792 Date posted 07/10/2024 Location Social Circle, Georgia

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Job Description

About the role:

You will manage, plan, organize, direct and evaluate all activities and staff of the Analytical Chemistry Department in the Quality Control Laboratory to ensure the safety and reliability of Takeda products, and to comply with Quality and Regulatory requirements. Work with manufacturing and product support teams to ensure product safety through Testing of Raw Materials, Critical Systems, In-Process Intermediates and Finished Drug Products. You will support Quality Control Programs to improve safety, customer satisfaction, employee development, continuous improvement, and financial performance consistent with Plant goals. You will make critical decisions to disposition raw materials, in-process and finished product testing results for release promptly. Identify potential risks associated with laboratory operations and lead teams to resolve lab issues. Be a representative for the Quality Laboratory during Regulatory Inspections and Customer Audits. Lead troubleshooting activities for assays issues. Support regulatory filings, submission review and data analysis. You will report to the Head of Quality Control.

How you will contribute:

  • Provide Analytical Chemistry group long-term goals, general policies and management guidance based on business directions and goals.
  • Provide Quality Laboratory management guidance to policies based on business directions and goals.
  • Interpret applicable quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules and guidelines); develop policies to implement these requirements for laboratory operation.
  • Ensure compliance with testing procedures, specifications and company policies. Prepare the department for both internal and external authorities. Be a Quality representative for the lab and interface with investigators and customers.
  • Work with manufacturing teams in proactive functions that impact production, solve problems, improve quality, increase efficiency, create cost savings, and provide new product support. Support complex investigations and trending laboratory results.
  • Improve operating mechanisms to ensure that non-conformances (OOLs, OOSs, and CAPAs) are completed.
  • Responsible for guidance on creation, changing and issuance of lab related documents.
  • Assure a safe and non-discriminatory working environment for employees.
  • Manage operating budget for lab/ teams.
  • Ensure employees are trained and audited. Make appropriate staffing recommendations. Evaluate performance through performance appraisals and ensure employees have development plans. Develop team.
  • Interacts frequently with internal subordinate superiors and senior groups.
  • Manage continuous improvement projects with objective of achieving quality, reliability and cost improvements. Improve understanding to all laboratory levels.
  • Responsible for the process of evaluating new technology for the lab and subsequent validation.
  • Responsible for assay troubleshooting, trending and supporting complex investigations
  • Hire and retain great talent; develop and provide challenging work for team members; support the career development of their employees both within their current position as well in situations where employees move on to different roles within the Takeda organization; manage performance and differentiate compensation and development; plan for future talent needs; improve performance Knowledgeable about Quality Laboratory operations and government regulations about pharmaceutical manufacturing labs.
  • Manage complex projects, resolve complex issues, critical problem solving.
  • Have project and people management skills. Manage a large team of employees.
  • Have advanced knowledge in Statistical Analysis, QSR, cGMP, CFR, USP and GDP.

What you bring to Takeda:

  • Bachelors' Degree in Chemistry or Biological Science.
  • 8+ years of related experience with 3+ in a management role.
  • 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.
  • 5% Travel

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. You may:

  • May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
  • Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
  • Work in a cold, wet environment.
  • 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.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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.

#GMSGQ #ZR1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - GA - Social Circle - Hwy 278

U.S. Base Salary Range:

$149,100.00 - $234,300.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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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Working at Takeda

  • Inclusion

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

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

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

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

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

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

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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About our location

Social Circle, Georgia


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