Manager, Quality Assurance (R&D) Job in Waukegan 60085, Illinois US
Manager, Quality Assurance (RD)
Job Title: Manager, Quality Assurance (RD)
Accountabilities
Responsible for ensuring CareFusion Infection Prevention RD activities have the appropriate systems and support for compliant, right-first-time product launches. The position is responsible QA related RD activities from Research through product launch. The position will also manage contract manufacturers and supplier quality. The person will ensure the department is appropriately staffed, trained with clear succession planning.
- The person should have a working knowledge of ICH Quality Gudance, in particular ICH Q6, Q8, Q9, Q10. This knowledge will be leveraged to deploy Quality by Design principles in product development.
- This position will have a detailed working knowledge of risk management principles and ensure the risk management file is compliant and complete from risk planning to the risk report.
- The person will be knowledgeable of ISO 13485 and design control. This position will ensure the design history files, technical files and design dossiers are compliant, with an approved Declaration of Conformity, and audit ready.
- This person will ensure the quality related aspects of design transfer and new product integration into operations are right-first-time.
- This person will ensure quality related aspects of controlling contract manufacturers and suppliers are done in a compliant and cost efficient manner. Maintenance of an effective supplier management program is central to the function includes the quality supplier scorecard, supplier audits and approving supplier corrective actions.
Job Family Summary
Quality Assurance for RD and Supplier Quality
- Qualified candidates will have a Bachelors degree in a relevant technical degree and minimum 6 years of drug experience with emphasis on RD, Design control and risk management.
- Strong pharmaceutical background is required with medical device experience preferred.
- Thorough understanding of the risk management and quality by design is preferred
- Background in statistics and DOE preferred
- Demonstrated ability as critical thinker in developing product quality strategies
- Attentiveness to details with strong organizational skills
- Ability to work proactively and independently
- Ability to multi-task and efficient in time management
- Excellent verbal communication and interpersonal skills with the ability to work in a team environment and influence others positively
- Ability to provide constructive criticism and promote a positive work environment
- Comprehensive knowledge of clinical/safety databases, coding dictionaries, and regulatory guidelines (ICH) is required
- Proficiency in Excel, Word, and other desktop/general business and safety computing systems.
- Strong interpersonal skills.
- Strong process management and communication skills
June 10, 2007
• Tags: Illinois Us, Manager, Quality Assurance (R&D) Job in Waukegan 60085 • Posted in: General