Product Quality Manager
Just-Evotec Biologics is seeking a highly motivated Product Quality Manager, who will function as a Product Quality Liaison to support our mission of advancing low-cost biotherapeutics manufacturing to improve worldwide access. The PQL is a member of the Product Quality Team within the Quality organization and is responsible for ensuring the highest product quality and maintaining adherence to all applicable regulations, standards, and guidelines. This PQ liaison works closely with Just’s Process & Product Design, Manufacturing Science & Technology, and Quality Control teams as well as the Client to provide assurance and oversight of technical aspects of Quality throughout the lifecycle of the product. The PQ liaison will support activities ranging from new product introduction, technology transfer, process and performance qualifications, commercialization, and continuous process verification.
Responsibilities
- Helps ensure product quality throughout product lifecycle.
- Partner with all relevant departments to ensure timely completion of deliverables for NPI, tech transfer, PPQ, and CPV.
- Assists in managing Quality issues with Client Quality organizations.
- Maintain strong relationships with multiple internal and external team members and cross functional groups.
- Support the development and/or improvement of SOPs related to PQL activities and maintain a mindset for continuous improvement and learning.
- Perform quality document review and approval as required.
- Perform investigations of product related quality issues, deviations, and root cause investigations.
- Travel to JEB local sites as required.
Qualifications
- Bachelor's degree Life/Health Sciences; master’s degree and/or Ph.D. a plus.
- Minimum 6-8 years’ experience in biopharmaceutical or related industries in manufacturing, Product Development or MSAT, QC or QA. Experience at CDMO a plus.
- Knowledge of FDA, EMA and MHRA regulations and guidelines. Experience with biosimilar filings a plus.
- Excellent verbal and written communication skills.
- Knowledge of QMS and CAPA related processes and systems is required.
- Ability to work across functional areas and foster a collaborative culture of quality within the organization.
- Experience with NDA and/or BLA submissions and Inspection readiness for Sponsors is strongly desired.
This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve
The base pay range for this position at commencement of employment is expected to be $92,400 to $126,500; Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
What We Do
Evotec is a biotechnology company that is committed to advancing drug discovery and development. Through flexible business models, we collaborate with pharmaceutical companies, biotechs, foundations, and government agencies on a substantial scale. We believe that by working together, we can make a difference in the lives of patients.
Our Pipeline Co-Creation model represents our adaptable, multi-modality, fully integrated end-to-end approach to drive collaborations and services across all phases of drug discovery and development – from discovery of novel targets to achieving Proof of Concept in the clinic and into commercial manufacturing.
We aspire to contribute data-driven disease understanding and early disease relevance in humans to bring the probability of success up. We select the right modality, which is then propelled forward on our platforms by our passionate people striving for the fastest and most effective ways towards patient impact. This is enabled by convergence of human ingenuity with data and AI.
We also offer specific solutions, products, and CRO/CDMO-like services, always in support of the Biopharma R&D innovator. Our more than 4,000 scientists work closely with numerous partners concurrently, delivering fully integrated research and development portfolios or individual projects with the highest quality standards and efficiency, coupled with great science, passion, engagement, and communication.
