Manager/Director, Technical Regulatory managing regulatory submissions for pharmaceutical products. Ensuring compliance with local and global standards in order to support timely approvals.
About the role
- Manufacturing Compliance Specialist ensuring GMP compliance and leading deviation investigations at Just Evotec Biologics. Collaborating on critical quality initiatives and providing training within the team.
Responsibilities
- Improve the technical capabilities and quality practices within the department
- Coordinate activities and resolve issues across the department, other groups, and/or projects
- Respond to and/or resolve recurring technical or processing issues
- Develop and implement novel approaches to solving non-routine technical problems
- Communicate information effectively through updates, reports, and summaries
- Lead improvements in processes and methods that reinforce cGMP within the department and/or across the site
- Participate directly in internal, external, and global health authority audits/inspections
- Apply systematic thinking processes and technical knowledge to independently address a broad range of non-routine to moderately complex problems
- Conduct investigations, demonstrate strong technical and problem-solving skills, and excellent technical writing skills
- Provide training and guidance on the staff to meet the goals of the department
- When appropriate, assist in providing leadership on project teams
- Represent the department as the SME and lead multi-disciplinary teams or committees
- Provide routine updates on progress, status, and issues associated with campaigns/projects
- Provide support and/or direction to junior staff when necessary
- Exercise sound judgment when making decisions
- Make critical decisions in collaboration with key stakeholders
- Demonstrate accountability for personal, departmental, and organizational initiatives
Requirements
- BA / BS in a science or engineering related discipline (Biology, Chemistry, Biotechnology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Manufacturing, Process Engineering)
- minimum 4 years plus years of experience or an Associate’s degree and 10 plus years of experience in a GMP manufacturing environment
- Previous hands-on experience in a regulated (eg GMP/Aerospace) operations environment
- Experience in investigating and helping to resolve production non-conformances, implementing CAPA, and leading improvement projects
- Strong proficiency in Microsoft Word, Excel, PowerPoint
- Familiar with other operations enterprise systems such as DeltaV, MES, and SAP
- Strong leadership, organizational, communication, technical and writing skills
Benefits
- 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
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