Job description
Just-Evotec Biologics (JEB) is seeking a highly motivated Director, Global QEV that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to provide Quality oversight for validation life-cycle activities at JEB. This highly qualified candidate will partner with Manufacturing Operations, Technical Operations, Facilities & Engineering, Materials Management, and EH&S functions to ensure plant -readiness and ongoing operational success.
The position is part of the Just-Evotec Biologics Quality Senior Leadership Team and will report directly to SVP, Quality. In this role, the successful candidate will partner with quality site-heads, Technical Operations, ensure Validation Lifecyle process is in place for J.POD facilities and associated Quality systems; ensuring that these are suitable for phase 3 manufacturing and pre-positioned to be commercially compliant, inspection ready, and licensable by US FDA and EMA health authorities.
Key job responsibilities will include, but is not limited to:
- Review and approve validation master plan, commissioning, qualification, validation protocols and reports
- Manage Quality Assurance validation oversight of facility, equipment, utility, method, computerized system, and process.
- Provide Quality Assurance support to the validation team during the document review to ensure the validation activity complies with SOPs and regulatory requirements
- Provide QA oversight for facility and equipment design reviews
- Develop and implement integrated and sustainable Digital Quality Assurance strategies, and activities for Just’s clinical and commercial products supporting a robust compliant lifecycle for the digital programs.
- Define this new function and identifying solutions and processes, and aligning with key partners on implementation of new requirements as Just evolves its digital strategy for QA and for its GxP systems
- Drive strategy and direction of CS-QA to ensure and sustain compliance of digital solutions and technologies with modern global Computer System Validation related standards.
- Review and approve Discrepancy, Investigation, Change Control, and CAPA related to the Validation.
- Support internal and external audit programs
Educational Requirements:
- BS, MS in Engineering or in life-sciences with 10+ years of validation experience in the biopharmaceutical GMP functions
Qualification Requirements:
- Proven Quality leader with substantial experience in the pharma/biotech manufacturing or service business or similar responsibilities in pharmaceutical or biopharmaceutical companies
- Strong management and leadership skills, including establishment of clear expectations and development of metrics and KPIs to monitor performance and ongoing activities
- Ability to deal with complexity, ambiguity, and multiple priorities simultaneously.
- Extensive experience and proven track record of success for Quality oversight of late-stage and commercial biologics drug substance and drug product manufacturing
- In depth knowledge of 21 CFR 210, 21 CFR 211, ICH Q7, ICH Q9, ICH Q10, Eudralex – Volume 4, and Data Integrity and Compliance with cGMP and GAMP
- Deep understanding of biologics validation
- Experienced in the use of electronic systems such as eQMS, LIMS, MES/EBR, and ERP systems
- Candidate must possess strong focus on attention to detail
- Possess effective task/time management organizational skills
- Good interpersonal, team, and communication skills are a must
- Ability to communicate effectively over teleconference and web-based meetings are necessary.
- Strong computer skills include Microsoft Office (Word, Excel, Power Point, and MS Project)
Additional Preferred Qualifications:
- Knowledge and expertise to solve complex technical problems
- Active participation/lead technical projects with collaborators and vendors
The base pay range for this position at commencement of employment is expected to be $175,000 to $215,000; Base salary offered may vary depending on 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.
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