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Director, IGIV Production
GrifolsDirector of IGIV Production overseeing Bulk IGIV manufacturing operations in a global healthcare company. Responsible for achieving production goals and ensuring regulatory compliance across all operations.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in FDA regulated manufacturing operations, with a strong focus on cGMP compliance, project management, and team leadership. Proven ability to enhance manufacturing efficiency while ensuring product quality and regulatory adherence.
Highest-signal resume keywords
FDA RegulationsCGMP KnowledgeProject ManagementManagerial ExperienceTechnical Writing Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Operations ManagementManufacturing EfficiencyRegulatory ComplianceDeviation InvestigationAnalytical SkillsProblem-Solving SkillsBudget ManagementPerformance EvaluationScientific AdviceSuccession Planning
Soft Skills
Excellent CommunicationInterpersonal SkillsOrganizational SkillsLeadership SkillsTeam Development
Industry Keywords
Pharmaceutical IndustryBiologicsBiotechMedical Device IndustryQuality AssuranceInternal InspectionsRegulatory InspectionsManufacturing AssuranceProduction GoalsRoot Cause Analysis
About the role
Key responsibilities & impact- Responsible for direct leadership over Bulk IGIV manufacturing operations, ensuring production goals are achieved through current Good Manufacturing Processes
- Oversees the 24/7 day-to-day operations of the Bulk IGIV manufacturing group, evaluating performance towards the achievement of production goals while maintaining regulatory compliance and minimizing errors
- Assumes the decision-making responsibility for day-to-day operations considering staff input and collaborating closely with other functions (i.e. Quality, Maintenance, Validation, Engineering, etc)
- Directly supervises IGIV manufacturing managers and supervisors, including hiring, developing, and motivating in a manner that promotes the achievement of IGIV manufacturing’s business goals and objectives
- Manage and monitor IGIV Manufacturing operating budget
- Meets all production and release requirements, maximizing yields and efficiency and reducing quality issues
- Partner with the Quality and Manufacturing Assurance groups to review deviation investigation reports for accuracy and identify root cause/ corrective actions for IGIV Purification related incidents
- Build organizational competency and succession plans
- Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsible
- Provide scientific and/or technical advice and counsel regarding projects as needed
- Develops and challenges managers and supervisors to find ways to improve manufacturing efficiency and reduce costs while maintaining product quality and compliance
- Maintains clear communication with the VP of Manufacturing regarding goals, projects, planning, and overall performance of the bulk manufacturing group
Requirements
What you’ll need- Master’s degree or Ph.D. in Computer Science, Engineering, Biology, Chemistry, Biochemistry, Physical Science, or related scientific/technical discipline
- Minimum 10 years of operations experience in an FDA regulated manufacturing facility - pharmaceutical, biologics, biotech, or medical device industry
- Minimum 5 years of managerial experience in an FDA regulated environment
- Strong knowledge of cGMPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines
- Project management experience
- Excellent verbal and written communication
- Must be able to read, write, and speak English
- Must have strong technical writing skills
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner
- Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment
- Strong organizational, analytical and problem-solving skills
- Ability to analyze details and perform structured decision-making on a daily basis
Benefits
Comp & perks- Medical
- Dental
- Vision
- life insurance
- PTO
- paid holidays
- up to 5% 401(K) match
- tuition reimbursement