This position will oversee day to day operations of a 24/7, 5 Shift Operation of the QC Laboratory Logistics Team ( Van Nuys Sample Control, QC Documentation Control, Stability and QC Supply Management) and QC Site projects to support operational excellence (Kaizen, 5S, WEKE, Lean, Six Sigma, Agile 4.0) improvements. Manage daily operations of the lab inventories and lab support activities and control workflow to ensure operational efficiency with emphasis on continuous improvement and cost-effectiveness. The incumbent is responsible for providing investigation support to the Biochemistry and Microbiology Labs for issues requiring rapid and focused response. Support Quality Control Initiatives to drive improvements in safety, customer satisfaction, employee development, continuous improvement, and financial performance consistent with Plant Strategic Plan. Embed Quality Culture and champion Takeda-isms and values. Make decisions based on the Takeda principles of Patient, Trust, Reputation and Business and build upon those expectations. Serve as a representative for the Quality Laboratory during Regulatory Inspections and Customer Audits.
Essential Duties and Responsibilities
- Ensure transfer of all samples, including but not limited to In-process, On-demand, final container, special project, protocol, non-routine samples, etc. in a timely manner to support testing that achieves fulfillment and commitment.
- Manage the Just-in-time lab inventories program and lab support activities proving supplies and necessary skillset tasks to QC lab testing.
- Monitor aliquoting techniques and review accuracy of records and documentation generated.
- Provide Quality Laboratory management guidance to policies based on business directions and goals.
- Interpret applicable quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules and guidelines); develop policies to implement these requirements for laboratory operation.
- Ensure compliance with testing procedures, specifications and company policies. Prepare the department for both internal and external authorities. Serve as a Quality representative for the lab and interface with investigators and customers.
- Work closely with laboratory and manufacturing teams in proactive functions that impact production, solve problems, improve quality, increase efficiency, generate cost savings, and provide new product support. Responsible for leading and / or supporting complex investigations and trending laboratory results.
- Manage and improve operating mechanisms to ensure that Laboratory non-conformances and Quality Systems records are completed in an effective and timely manner.
- Manage the laboratory responsibility for annual product review to ensure effective and timely completion of responsibilities.
- Responsible to ensure that sample custody and integrity is maintained and managed for samples received into the laboratories and sent out to external test facilities.
- Responsible for guidance on creation, changing and issuance of lab-related documents.
- Responsible for ensuring that lab supplies are procured in a timely manner to match demand while establishing necessary inventory controls.
- Prepare QC Metrics for Business Unit Review.
- Assure a safe and non-discriminatory working environment for employees.
- Develops and manages operating budget for lab/ teams.
- Ensure employees are properly trained and audited. Make appropriate staffing recommendations. Evaluate performance via performance appraisals and ensure employees have development plans. Mentor and develop a strong team.
- Interacts frequently with internal subordinate superiors, functional per and senior groups.
- Identifies and manages continuous improvement projects with objective of achieving quality, reliability and cost improvements. Drive continuous improvement understanding to all laboratory levels.
- Hire and retain great talent; develop, coach and provide challenging work for team members; support the career development of their employees both within their current positon as well in situations where employees move on to different roles within the Takeda organization; aggressively manage performance and differentiate compensation and development; plan for future talent needs; improve performance of individuals and teams.
- Knowledgeable about Quality Laboratory operations and government regulations pertaining to pharmaceutical manufacturing labs. (Strong emphasis in investigations and problem-solving).
- Ability to manage complex projects, resolve complex issues, critical problem-solving.
- Possess excellent supervisory and interpersonal skills and be able to communicate with all level personnel and regulatory authorities.
- Possess strong leadership, project and people management skills. Ability to develop, mentor and manage a large team of employees.
- Should have advanced knowledge in Statistical Analysis, QSR, cGMP, CFR, USP and GDP. Strong leadership, project and people management skills, and ability to make critical decisions. Strong understanding of the Biopharmaceutical business and/or industry.
Education and/or experience
- Typically requires bachelor's degree in chemistry, biological science, or other related technical field. 6+ years of related experience with 1+ years as a supervisor.
- Must be able to lift, push, pull and carry up to 15 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Will work in a cold, wet environment.
- Must be able to work multiple shifts & weekends as required in support of a 5 shift 24/7 operation.
- Must be able to work overtime as required.
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
- 15% travel/ between Van Nuys and Los Angeles locations.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.