One of the world’s leading companies in the fields of health and nutrition, delivering breakthrough innovations in healthcare and agriculture. Contribute to a world in which diseases are not only treated but effectively prevented or cured, in which people can take better care of their own health needs, Join this team which is Guided by the purpose “Science for a better life”
This is a hybrid role with 2x/week expectation on site. Local Candidates only
This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
POSITION SUMMARY
Focus is internal. Leads cross-functional teams and interfaces with external groups on tasks/assignments relating to deviation and change management. Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.
POSITION DUTIES & RESPONSIBILITIES
Deviation Management
- Investigate discrepancies using root cause analysis (RCA) methodologies. Recommend corrective/preventative actions (CAPAs) based on root cause investigations to eliminate recurrence.
- Lead multi-discipline teams to complete investigations, or for the purpose of Continuous Improvement
- Influences direction of investigations and communicates with all levels of employees
- Write concise, accurate and effective deviation reports for investigations that meet compliance expectations
Change Management
- Coordinate and manage change applications (Local and Global).
- Maintain alignment of Global Standard Operating procedures (GSOP) and Operational Instructions (GOI) to local procedures.
- Support CMS Chapter Owners and Representatives by maintaining compliance. Update and upgrade CMS Chapters.
- Support process development/improvement projects, site-wide and global projects.
REQUIREMENTS/PREFERENCES
Education Requirement(s):
- Minimum Education B.S. degree in a Science related field, i.e. Engineering, Biology, Chemistry, etc.
- Minimum Experience BS 6+ years
- MS 0-4+ years of experience in a related field such as: Engineering, Quality, or Manufacturing in the pharmaceutical industry or an equivalent combination of education and experience
Skill & Competency Requirements:
MUST have experience/expertise in cell and gene therapy manufacturing
- Knowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, HVAC systems, process instrumentation and control systems, etc.
- Experience with regulatory and cGMP requirements for pharmaceutical manufacturing
- Strong analytical skills to identify root causes and prepare balanced decisions
- Ability to plan and prioritize complex and conflicting activities; act in a speedy and pragmatic manner, adapt quickly to changing environments, without sacrificing quality and long-term goals.
- Strong written and verbal communication skills, and effective presentation skills and ability to adjust presentation style to accommodate various audiences.
Preferences
- SAP, ValGenesis
- Deviation Management/Quality Management Software (e.g. Trackwise, Sparta, Werum Pas-X)
- Risk Assessments
- Authoring/Reviewing Documents for Regulatory Review
- Lean Six Sigma and Continuous Improvement Methodology
- Project Management Professional (PMP)
Travel Requirements: (if applicable)
