Director of Quality Assurance and Compliance
2 weeks ago
Takeda Pharmaceutical is seeking a highly skilled and experienced professional to fill the position of Director of Quality Assurance and Compliance. As a key member of our Global Manufacturing & Supply and Global Quality (GMSGQ) team, you will be responsible for ensuring the highest level of product quality and compliance with industry standards and regulations.
Key Responsibilities:- Develop and implement quality control standards and procedures to ensure compliance with industry regulations and company policies.
- Manage and oversee the quality control laboratory functions, including analytical chemistry and microbiology.
- Collaborate with manufacturing and quality leaders to drive improvements in safety, quality, compliance, financial performance, employee development, customer satisfaction, and digital and continuous improvement initiatives.
- Ensure compliance with internal standards and industry regulations, staying current with any changes or updates.
- Act as a subject matter expert and advisor to subordinates to meet schedules and/or resolve technical problems.
- Periodically review the suitability and effectiveness of the quality control system with senior management.
- Identify and manage continuous improvement projects that may span multiple sections or departments to achieve quality, reliability, and cost improvements.
- Develop and manage budgets to ensure adherence to financial targets.
- Manage overall coaching, training, development, and succession plans for the team.
- Develop and maintain a site contamination control program with a focus on sterility assurance.
- Responsible for identifying and implementing digital innovation for the QC laboratory.
- Bachelor's degree in a science, engineering, or other related technical field.
- 10+ years of related experience, with 7+ years in a management role.
- Experience in running a large-scale, multi-function laboratory is strongly preferred.
- In-depth knowledge of industry standards and regulations related to quality control.
- Knowledge of FDA, EMA, CFDA, PDA Regulations, Good Data and Documentation Practices (GDDP), and application of current Good Manufacturing Practices (cGMP).
- Manages regulatory inspections and other pre-inspection readiness audits.
- Interacts with local and global regulators and is the key contact for regulatory inspections involving the laboratory.
- Experience with endotoxin and sterility testing is preferred.
- Strong analytical and problem-solving skills.
- Ability to work with multifunctional, global teams in a fast-paced setting.
- Strong leadership skills and demonstrated success in managing a large team.
- Prior experience in interfacing and/or leading regulatory audits.
- Ability to manage department budgets and staffing.
- Result-driven with ideas to drive continuous improvement and process simplification with breakthrough solutions, including digital.
- Knowledge of data analytics and Lean / Six Sigma concepts preferred.
- Understanding of new innovative laboratory concepts.
- Must be able to manage ambiguity and make decisions under stressful conditions.
- Challenges the status quo to drive continuous improvement and enhancements to operations in the Quality Control Department.
- Must be able to work in controlled environments requiring special gowning, follow gowning requirements, and wear protective clothing over your head, face, hands, feet, and body.
- Make-up, jewelry, contact lenses, nail polish, or artificial fingernails may not be worn in the manufacturing environment, which is cold and wet in some areas and requires personal protective equipment (PPE).
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
- Must be able to work multiple shifts, including weekends.
- 10% Travel
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Director of Quality Assurance and Compliance
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Social Circle, Georgia, United States Takeda Pharmaceutical Full timeAbout the RoleWe are seeking a highly experienced and skilled Director of Quality Assurance and Compliance to join our team at Takeda Pharmaceutical. As a key member of our Quality Control Laboratory, you will be responsible for managing, planning, organizing, directing, and evaluating all activities and staff to ensure the safety and reliability of our...
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Social Circle, Georgia, United States Takeda Pharmaceutical Full timeAbout the Role:We are seeking a highly experienced and skilled Director of Quality Assurance to join our team at Takeda Pharmaceutical. As a key member of our Quality Control Laboratory, you will be responsible for managing, planning, organizing, directing, and evaluating all activities and staff to ensure the safety and reliability of our products, and to...
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Social Circle, Georgia, United States Takeda Pharmaceutical Full timeAbout the Role:We are seeking a highly skilled Sr QA Technician to join our team at Takeda Pharmaceutical. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our manufacturing processes.Key responsibilities include:Inspecting production materials, components, and chemicals to ensure...
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