Senior Product Quality Technical Manager
Evotec
4 hours ago
Remote friendly (Redmond, WA)
United States
Operations
Responsibilities:
- Ensure product quality throughout the product lifecycle.
- Partner with relevant departments to complete deliverables for NPI, tech transfer, PPQ, and CPV on time.
- Serve as the single point of contact for quality issues with Client Quality organizations.
- Maintain strong relationships with internal and external stakeholders and cross-functional teams.
- Support development and/or improvement of SOPs related to PQL activities; maintain a mindset for continuous improvement and learning.
- Perform quality document review and approval as required.
- Oversee investigations of product-related quality issues, deviations, and root cause investigations.
- Travel to JEB local and international sites as required.
Qualifications:
- Bachelor’s degree in Life/Health Sciences; master’s degree and/or Ph.D. a plus.
- Minimum 10 years’ experience in biopharmaceutical or related industries in manufacturing, Product Development or MSAT, QC or QA; CDMO experience a plus.
- Knowledge of FDA, EMA, and MHRA regulations and guidelines; biosimilar filings experience a plus.
- Excellent verbal and written communication skills.
- Knowledge of QMS and CAPA processes and systems is required.
- Ability to work across functional areas and foster a collaborative quality culture.
- Experience with NDA and/or BLA submissions and sponsor inspection readiness strongly desired.
Application instructions:
- Apply today.
- Ensure product quality throughout the product lifecycle.
- Partner with relevant departments to complete deliverables for NPI, tech transfer, PPQ, and CPV on time.
- Serve as the single point of contact for quality issues with Client Quality organizations.
- Maintain strong relationships with internal and external stakeholders and cross-functional teams.
- Support development and/or improvement of SOPs related to PQL activities; maintain a mindset for continuous improvement and learning.
- Perform quality document review and approval as required.
- Oversee investigations of product-related quality issues, deviations, and root cause investigations.
- Travel to JEB local and international sites as required.
Qualifications:
- Bachelor’s degree in Life/Health Sciences; master’s degree and/or Ph.D. a plus.
- Minimum 10 years’ experience in biopharmaceutical or related industries in manufacturing, Product Development or MSAT, QC or QA; CDMO experience a plus.
- Knowledge of FDA, EMA, and MHRA regulations and guidelines; biosimilar filings experience a plus.
- Excellent verbal and written communication skills.
- Knowledge of QMS and CAPA processes and systems is required.
- Ability to work across functional areas and foster a collaborative quality culture.
- Experience with NDA and/or BLA submissions and sponsor inspection readiness strongly desired.
Application instructions:
- Apply today.