Sr. Manager, Document Management Process Owner

Just-Evotec Biologics is seeking a highly motivated Sr. Manager DMS QA, that desires a significant opportunity to improve worldwide access to biotherapeutics.

The position is part of the Just-Evotec Biologics Quality team and will report directly to the Director of QMS. In this role, the successful candidate will:

• Manage the Document Management process from creation to archival.
• Maintain and implement as appropriate, policies and procedures regarding document creation, revision, and obsoletion; document storage, sharing, transmission, and destruction.
• Evaluates existing content and document management process and procedures to determine current effectiveness and efficiency;
• Act as Business Owner of the electronic Document Management System for the site, including implementation, maintenance, and issue support and resolution as necessary.
• Supports GMP inspections and audits from both regulatory authorities and partners and supports drafting of follow-up responses for all aspects of the business.
• Supports other GXP functions as required.
• Participates in the recruitment, selection, and/or promotion, termination, and performance management of QA employees
• Other duties as required.

Educational Requirements:

• BS, MS. in Biochemistry, Biology, Microbiology, Chemistry or a Scientific/Engineering degree
• 8+ years of in biotechnology or biopharmaceutical experience in a commercial manufacturing environment.

Qualification Requirements:

• knowledge of cGMP in the pharma/Biotech industry
• Experience with performing/participating in risk assessment exercises.
• Experience in document management system.
• Quality performance / continuous improvement oriented – e.g.
  • Able to create and maintain meaningful metrics for assigned activities.
  • Able to recognize trends in product data and results.
  • Able to assess and recommend improvement measures to processes; able to drive implementation accordingly.
  • Ability to make independent and objective decisions and to work with cross functional teams and partners worldwide.
• Team spirit. Action-oriented and customer-focused.
• Negotiation and persuasion skills.
• 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:

• Entrepreneurial drive to achieve business objectives
• 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 $140,000 to $165,000; 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.