Manager Quality Systems and Compliance
- Lead the activities of the Quality System and Compliance department in the Quality organization. Responsibilities include oversight of document control, change control, quality related training, CAPA, complaint management for 2 sites.
- Responsible for coordination of quality system management review and internal / external audits.
- Responsible for results in terms of product quality and conformance to regulations and Baxter quality policies.
- Leads the activities of the Quality System and Compliance department in the Quality organization with responsibility for results in process quality.
- Implements the quality system procedures to the site and manages compliance.
- Responsible for strategy and implementation of the internal audit
- Understands and assures conformance to regulations and Baxter quality policies applicable to the site. Interfaces with regulators during inspections.
- Participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
- Leads quality management reviews and, develops and manages metrics
- Interacts frequently with internal supervisors, functional peer and senior management
- Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
- Works closely with Manufacturing in areas of GMP compliance
- Develops budget for the department and ensures adherence to the budget.
- Manages coaching, training and development of subordinates.
- Thorough knowledge of applicable procedures, specifications, FDA QSR regulations and ISO standards.
- Excellent people and organizational skills, Ability to manage/coach/supervise a team
- Strong analytical and problem solving skills.
- Strong communication and leadership skills.
- Strong interpersonal/communication/influencing/negotiation skills
- Strong project management skills.
- Experience with inspections by the FDA & Certified Body
- 5 – 8 years of manufacturing experience.
- Lean manufacturing background, preferred.
- Six Sigma background, preferred.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.