Head of Quality Compliance and Systems

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. Minimum Requirements/Qualifications: 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.

Salary : $154,000 - $241,000