Head of Medical Operations

Job Title: Quality Operations Manager

The Quality Operations Manager is responsible for the quality oversight of laboratory testing operations in two lab locations in accordance with established Standard Operating Procedures (SOPs), applicable sections of the Code of Federal Regulations (CFRs), with emphasis on Good Manufacturing Practices (GMPs), the Clinical Laboratory Improvement Act of 1988 (CLIA), and applicable Takeda and BioLife policies, and quality initiatives.

Main Responsibilities:

• Manages through subordinates the coordination of the activities of the Quality Operations Organization of two lab locations.
• Is responsible for results in terms of testing quality and conformance to regulations and Takeda quality policies.

Duties and Responsibilities:

1. Establishes and oversees quality operations to ensure accuracy and appropriate sample testing is performed, completed, and reported in a timely manner.
2. Reviews testing, quality control, process variation, equipment maintenance, and other reports to ensure that quality standards, efficiency, and schedules are met.
3. Ensures that consistent systems in both lab locations are in place to assure product quality.
4. Evaluates laboratory systems, processes, procedures and equipment as they relate to established regulatory and quality requirements and consistency between two lab locations.
5. Partners with internal audit team on internal quality assurance audits to evaluate laboratory systems to ensure compliance and quality.
6. Partners with Validation Department for equipment and computer qualification, process validation, and revalidation after repairs to ensure requirements are met for both lab locations.
7. Partners with Quality Systems Department to ensure proper oversight and corrective/preventive actions are executed, implemented and monitored through established quality systems for both lab locations
8. Partners with CLIA Director/Designee to monitor CLIA and other proficiency testing programs to ensure adequacy of test methods, equipment and personnel competency for both lab locations.
9. Be a member of the audit support team to prepare for and participate in FDA, CLIA, EMEA, BioLife, OSHA and other inspections.
10. Lead operational excellence initiatives on the lab floor for both lab locations for the Quality Operations Department to drive a culture of continuous improvement to achieve site operational excellence goals (including but not limited to 5S, Value Stream Mapping and Kaizen.
11. Works in conjunction with Mangers of Quality Systems, Validation, Training, Lab Services and Laboratory Operations in the implementation, monitoring, and maintenance of laboratory quality systems.
12. Interviews, hires, and supervises performance of laboratory quality assurance staff for the lab floor of 2 lab locations.
13. Ensures that proper training of laboratory quality assurance staff of the lab floor is performed and documented in 2 lab locations.
14. Other duties as assigned or necessary for proper quality oversight of lab operations

Requirements:

• Demonstrate work history of above average performance and attendance.
• Proficiency in the use of personal computers and software programs including Microsoft Word, Excel and PowerPoint.
• Ability to work in an office / production environment.
• Building trust with society.
• Developing the business.

Qualifications:

• Bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution;
• and have at least 7 years of laboratory training and/or experience, or both, in high/moderate complexity testing.
• 5 to 7 years' experience in a professional or technical capacity in a laboratory, blood services, or pharmaceutical manufacturing, including significant exposure to the regulatory requirements affecting that discipline or activity.
• Familiarity with regulated disciplines in a blood bank setting or a pharmaceutical manufacturing environment.
• 5-8 years management experience preferred.
• Travel up to 25% may be required

Benefits:

• The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
• S. based employees may be eligible for short-term and/or long-term incentives.
• 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.

About Us:

Takeda Pharmaceutical Company Limited 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.