Dir Quality
Los Angeles, CA
Req ID 51282BR
Business Title
Dir, Quality
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Los Angeles, CA
Shift_
1st
Job Description
•Manages the Quality organization (60-70 employees) in a large size plant in the area of Pharma specific to Bulk Manufacturing, Sterilization, Aseptic Filling, Lyophilization, Pasterurization and Packaging.
•Responsible for finished drug product release. Is responsible for results in terms of product quality and conformance to regulations and Baxter policies. May act as the Management Representative for Quality.
•Develops and deploys the quality systems (e.g. in-process quality, management review, CAPA, process control) that ensure products conform to defined requirements.
•Understands and deploys processes to assure conformance to regulations in a large size plant. Support, interacts and manages regulatory inspections.
•Periodically reviews the suitability and effectiveness of the quality system with executive management
•Interacts frequently with all levels of internal management as well as across facilities and business units.
•Manages interactions with customers and regulators concerning the quality of products, systems and processes.
•Identifies and manages continuous improvement projects that may span multiple sections or departments with the objective of achieving quality, reliability and cost improvements.
•Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility.
•Develops budget for a mid to large size plant or large programs/department and ensures adherence to the budget.
•Manages overall coaching, training, development and succession plans for the team.
Job Requirements
•In depth knowledge of the regulatory environment for manufacture of therapeutics/biologics.
•Strong leadership skills and demonstrated success in managing a large team.
•Strong analytical and problem solving skills
•Excellent verbal and written communication skills
•Success working with multifunctional, global teams.
•Excellent interpersonal/communication/influencing/negotiation skills required
•Demonstrated problem solving skills
•BS in science or engineering; advanced degree helpful.
•Minimum of 10 years experience in Bulk Manufacturing and/or Aseptic FIlling in or related field in the therapeutics/biologics industry.
•7 years management experience.
•Demonstrated success with organizational development, coaching and succession planning.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
