Takeda Pharmaceutical
Associate Director, Quality Control
Takeda Pharmaceutical, Social Circle, Georgia, United States, 30279
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Job DescriptionAbout 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.
5% Travel.
Important ConsiderationsAt 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.
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.
LocationsUSA - GA - Social Circle - Hwy 278
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
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Job DescriptionAbout 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.
5% Travel.
Important ConsiderationsAt 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.
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.
LocationsUSA - GA - Social Circle - Hwy 278
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
#J-18808-Ljbffr