Project Quality Assurance Validation Lead - Finished Production
Novo Nordisk
14 hours ago
On-site
Clayton, NC
Operations
The Position
Validation Lead (Project Quality) for IFP expansion projects. Provides comprehensive validation subject matter expertise (equipment, facility, cleaning, sterilization, product, process validation). Builds detailed knowledge of the Novo Nordisk validation procedures/validation manual and directs project areas in developing compliant validation strategies.
Relationships
Reports to Senior Project Manager, Site Capacity & Upfit.
Essential Functions
- Build SME understanding of Novo Nordisk science & risk-based validation procedures
- Provide SME level knowledge to project groups
- Lead the development of all electronic validation structure
- Identify and implement lean project execution activities
- Translate validation procedural requirements into practical workflows guiding project execution
- Identify and implement improvements supporting lean project execution
- Build strong cross-functional relations with Novo Nordisk project organization and validation contributors (local & abroad)
- Other accountabilities, as assigned
Qualifications
- Bachelor’s degree in pharmaceutical, engineering, or other technical science field (or equivalent education/experience) required
- MA/MS preferred
- Minimum 8 years equipment & facilities validation experience preferred
- SME experience from pharma production preferred
- Knowledge of Novo Nordisk science & risk-based validation procedures preferred
- Proven experience with quality systems, preferably in pharma preferred
- Experience developing/implementing/validating/maintaining equipment & facilities preferred
- Project execution experience preferred
- Understanding of lean/continuous improvement principles preferred
- Solid ability to link/translate validation procedures to hands-on project work preferred
- Experience working with external engineering consultants preferred
Benefits (explicitly listed)
- Leading pay and annual performance bonus; paid time off incl. 14 holidays; health/dental/vision effective day one; guaranteed 8% 401K contribution plus match option; 14 weeks paid parental & 6 weeks paid family medical leave; free access to Novo Nordisk-marketed products; tuition assistance; life & disability insurance; employee referral awards.
Validation Lead (Project Quality) for IFP expansion projects. Provides comprehensive validation subject matter expertise (equipment, facility, cleaning, sterilization, product, process validation). Builds detailed knowledge of the Novo Nordisk validation procedures/validation manual and directs project areas in developing compliant validation strategies.
Relationships
Reports to Senior Project Manager, Site Capacity & Upfit.
Essential Functions
- Build SME understanding of Novo Nordisk science & risk-based validation procedures
- Provide SME level knowledge to project groups
- Lead the development of all electronic validation structure
- Identify and implement lean project execution activities
- Translate validation procedural requirements into practical workflows guiding project execution
- Identify and implement improvements supporting lean project execution
- Build strong cross-functional relations with Novo Nordisk project organization and validation contributors (local & abroad)
- Other accountabilities, as assigned
Qualifications
- Bachelor’s degree in pharmaceutical, engineering, or other technical science field (or equivalent education/experience) required
- MA/MS preferred
- Minimum 8 years equipment & facilities validation experience preferred
- SME experience from pharma production preferred
- Knowledge of Novo Nordisk science & risk-based validation procedures preferred
- Proven experience with quality systems, preferably in pharma preferred
- Experience developing/implementing/validating/maintaining equipment & facilities preferred
- Project execution experience preferred
- Understanding of lean/continuous improvement principles preferred
- Solid ability to link/translate validation procedures to hands-on project work preferred
- Experience working with external engineering consultants preferred
Benefits (explicitly listed)
- Leading pay and annual performance bonus; paid time off incl. 14 holidays; health/dental/vision effective day one; guaranteed 8% 401K contribution plus match option; 14 weeks paid parental & 6 weeks paid family medical leave; free access to Novo Nordisk-marketed products; tuition assistance; life & disability insurance; employee referral awards.