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.

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.