What are the responsibilities and job description for the Head of Quality Compliance and Systems position at BioSpace?
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Job Description
About the role:
As the Head of Compliance and Systems you will ensure compliance with all applicable provisions of the Takeda Quality Management System, and the regulations and standards applicable to Thousand Oaks operations. You will conduct gap analyses, implementing Quality Management System procedures across several departments, and managing compliance. You will interface with regulators during inspections, oversees Quality Council meetings, and manages the Product Complaint Management process. You will drive Risk management, Data Integrity, and fostering a strong Quality Culture at the site. You will report into the Site Quality Head.
How You Will Contribute
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 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 - CA - Thousand Oaks - Rancho Conejo
U.S. Base Salary Range
$153,600.00 - $241,340.00
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.
LocationsUSA - CA - Thousand Oaks - Rancho Conejo
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job Exempt
Yes
Job Description
About the role:
As the Head of Compliance and Systems you will ensure compliance with all applicable provisions of the Takeda Quality Management System, and the regulations and standards applicable to Thousand Oaks operations. You will conduct gap analyses, implementing Quality Management System procedures across several departments, and managing compliance. You will interface with regulators during inspections, oversees Quality Council meetings, and manages the Product Complaint Management process. You will drive Risk management, Data Integrity, and fostering a strong Quality Culture at the site. You will report into the Site Quality Head.
How You Will Contribute
- Conduct gap analyses and implement Quality Management System procedures in several departments
- Lead and interface with regulators during inspections, acting as an escort and SME concerning Deviation/CAPA, Change Control quality systems, Internal audit program, and Product Complaint Management
- Assure the appropriate execution of Quality Council meetings, including summaries of the data presented, conclusions, meeting minutes, and tracking action items to closure
- Support the team to execute annual Product Quality Reviews, monthly and quarterly reports needed to demonstrate the Quality performance of the site
- Review site-impacting regulatory and customer responses, working with Subject Matter Experts to assure timeliness and accuracy
- Manage the Product Complaint Management process and coordinate escalations for review associated with product hold, BPDR, and Field Corrective Action decision
- Work close to the Quality Incident team to ensure that issues are escalated in a time manner as well as closed according to Takeda standards
- Identify, manage, and lead multiple process/product improvement projects to achieve quality, efficiency, and cost improvements
- Drive and support Risk management, Data Integrity, and a strong Quality Culture at the site
- Assure the implementation and alignment of operations at the site with Takeda North Start systems
- Identify, investigate, and resolve quality issues and GAPs looking for continuous improvement and keep the site aligned with the most updated regulations, market trend and Takeda quality standards
- Manage overall coaching, training, development, and succession plans for the team
- Quality Leadership Team member (QLT), actively champion and role model our Quality Culture of continuous improvement, learning organization principles and innovation as well as adherence to the principles and values of Takeda-ism
- Serve as sponsor for key departmental and site projects
- Develop and adhere to the department budget
- Represent the Site Quality Head as needed and when it is requested.
- Bachelor’s degree in life sciences
- Minimum 8 years of related experience in pharmaceutical industries, aseptic process experience is desired
- Experience leading audit preparation and audit management program
- Experience in hosting quality inspections with HA agencies, especially FDA, EMA, ANVISA, PMDA, among others.
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 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 - CA - Thousand Oaks - Rancho Conejo
U.S. Base Salary Range
$153,600.00 - $241,340.00
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.
LocationsUSA - CA - Thousand Oaks - Rancho Conejo
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job Exempt
Yes
Salary : $153,600 - $241,340
