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You will be responsible for the Quality Assurance functions supporting Fractionation or Albumin or lg manufacturing, providing quality oversight over Critical Systems and Engineering Functions through subordinate staff. You will deploy compliant programs to bring the site from construction through to licensure and operational readiness. Manage, develop, and implement compliant strategies to ensure products meet appropriate regulatory agency requirements, internal company standards and current industry practices. Manages the Quality Assurance organization in support of Fractionation, lg purification and fill/finish operations, Albumin purification operation and quality oversight over Critical Systems and Engineering Functions. Is responsible for results concerning product quality and conformance to regulations and policies.

• Support the development of quality systems, deploy them into their organizations, and ensure products conform to defined requirements.
• Understand and deploy processes to assure conformance to regulations. Responsible for adherence to specifications and procedures that have been established to ensure product quality.
• Be an advisor to your team to meet schedules and resolve technical problems . Manage, identify, and recognize technical staff.
• Utilize understanding of theories and practices of a variety of disciplines to manage complex protects or roams within boundaries of actuality, time, budget and regulatory requirements.
• Manage regulatory inspections and other per-inspection readiness audits .
• Periodically review the suitability and effectiveness of the quality system with senior management.
• Manages continuous improvement projects that may span multiple sections or departments with the objective of achieving quality, reliability and cost
• improvements. Develop budget for their cost center(s) and ensures adherence to the budget.
• Manage overall coaching, training and succession plans for the team.

• Typically requires bachelors' degree in science, engineering or other related technical field.
• 10 or more years of related experience with 7or more in a management role.
• In-depth knowledge of the regulatory environment for manufacture of medical products .
• Strong analytical and problem-solving skills. Will break down complex problems and tasks into activities that can be performed by personnel.
• Candidate must excel at working within a dynamic, hands-on, team based environment with limited supervision.
• Strong leadership skills and demonstrated success in managing a large team
• Success working with nonfunctional, global teams .
• May be considered a Subject Matter Expert (SME) in multiple disciplines, particularly in the areas of purification of plasma based products (or other bio pharmaceutical manufacturing), aseptic filling (isolation experience is preferred), inspection and labeling/packaging.

• 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
• 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

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.

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.

Location and Salary Information: This post excludes CO 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.