Job Title:
Manufacturing Deviation Lead
About the Role:
We are seeking a Manufacturing Deviation Lead to manage manufacturing deviations for our organization. This role will be primarily responsible for leading investigations into fill/finish/inspection and packaging deviations.
Key Responsibilities:
* Lead deviation investigations, including establishing investigation teams, conducting root cause analysis, developing CAPAs, completing product impact assessments, and writing compliant documentation of all findings.
* Drive improvements to the investigation process.
* Present investigations to regulatory inspectors and internal auditors.
* Clearly communicate investigation progress to impacted areas and leadership.
* Coordinate and lead cross-functional teams through complex investigations and complete tasks on-schedule.
* Project manage the investigations end to end.
* Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
Qualifications:
* Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality).
* Detailed technical understanding of fill/finish operations.
* Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems.
* Experience leading complex investigations.
* Experience participating in and leading cross-functional teams.
* Experience managing multiple competing priorities in a fast-paced environment.
* Excellent technical writing skills.
* Excellent presentation and communication skills, ability to communicate and collaborate with technical and management staff.
Personal Attributes:
* Detail-oriented with a strong focus on quality and compliance.
* Ability to work under pressure and manage multiple priorities effectively.
* Proactive and self-motivated with a continuous improvement mindset.