Baxalta U.S., Inc.
Associate Director – Quality Control (Information Technology)
This position is responsible to manage, plan, organize, direct and evaluate all activities and staff of the Analytical Chemistry Department in the Quality Control Laboratory to ensure the safety and reliability of Takeda products, and to comply with Quality and Regulatory requirements. Work closely with manufacturing and product support teams to ensure product safety through Testing of Raw Materials, Critical Systems, In-Process Intermediates and Finished Drug Products. This position will support Quality Control Initiatives to drive improvements in safety, customer satisfaction, employee development, continuous improvement, and financial performance consistent with Plant objectives. This position will make critical decisions to disposition raw materials, in-process and finished product testing results for release in a timely manner. Identify potential risks associated with laboratory operations and lead teams to resolve lab issues. Serve as a representative for the Quality Laboratory during Regulatory Inspections and Customer Audits. Responsible for leading troubleshooting activities for assays issues. Supports regulatory filings, submission review and data analysis.
· Provide Analytical Chemistry group long term objectives, general policies and management guidance based on business directions and goals.
· 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 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 non-conformances (OOLs, OOSs, and CAPAs) are completed in an effective and timely manner.
· Responsible for guidance on creation, changing and issuance of lab related documents.
· 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 strong team.
· Interacts frequently with internal subordinate superiors 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.
· Responsible for the process of evaluating new technology for the lab and subsequent validation.
· Responsible for assay troubleshooting, trending and supporting complex investigations
· 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 position as well in situations where employees move on to different roles within the Shire organization; aggressively manage performance and differentiate compensation and development; plan for future talent needs; improve performance Knowledgeable about Quality Laboratory operations and government regulations pertaining to pharmaceutical manufacturing labs. (Strong emphasis and experience in Analytical Chemistry).
· 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. of individuals and teams.
Education and Experience Requirements
· Typically requires bachelor's degree in chemistry, biological science or other related technical field. 8+ years of related experience with 3+ in a management role.
Other Job Requirements
· 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, including weekends.
· Must be able to work overtime as required. (only for non-exempt positions)
· May be required to work in a confined area.
· Some Clean Room and cool/hot storage conditions.
· 5% Travel.
Job posting excludes CO applicants
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.