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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading sterile manufacturing operations while ensuring compliance with GMP regulations and quality standards. Proven ability to drive operational excellence through continuous improvement initiatives and effective team leadership.
Highest-signal resume keywords
Leadership ExperienceGood Manufacturing Practice (GMP)Aseptic Manufacturing OperationsQuality Management SystemsLean Manufacturing
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Biochemical AnalysisClinical ManufacturingPharmaceutical ProductionDosage FormsNew Product ResearchSpecification DevelopmentTeam LeadershipEvaluating New TechnologiesIdentifying Customer NeedsPatent Commercialization
Soft Skills
CoachingTalent DevelopmentOrganizational EffectivenessEmployee EngagementStructured Problem Solving
Tools & Technologies
Quality Management SystemsCompany Production SystemVisual Management
Industry Keywords
Regulatory ComplianceData IntegrityOperational EfficiencyContinuous ImprovementManufacturing EventsAuditsRisk AssessmentCorrective ActionsOperational ExcellenceCross-Functional Collaboration
About the role
Key responsibilities & impact- Provide visible, first-line supervision of sterile manufacturing operations and personnel
- Set daily priorities, assign work, coordinate support resources, and ensure effective shift handoffs
- Lead tier meetings, communicate schedule and performance expectations, and escalate safety, quality, staffing, or supply risks
- Review and approve manufacturing and compliance documentation as authorized by procedures
- Identify and recommend capital improvements for the shop floor
- Champion patient safety, product quality, data integrity, and regulatory compliance
- Ensure manufacturing activities comply with current GMP, regulatory requirements, site procedures, and quality standards, particularly aseptic behaviors
- Author, lead, or contribute to investigations of manufacturing events and deviations; assess root causes and implement corrective and preventative actions
- Maintain inspection readiness and support audits
- Ensure safe, compliant, and reliable manufacturing operations meet production schedules and customer requirements
- Monitor shift and area performance metrics and lead actions to address gaps
- Improve process robustness, cycle time, productivity, deviation reduction, and operational efficiency
- Make and escalate risk-informed decisions consistent with procedures and quality requirements
- Foster operational excellence through structured problem solving and continuous improvement initiatives
- Support value stream improvements and business process optimization using Lean Manufacturing and MPS methodologies
- Promote process stability, employee engagement, and organizational effectiveness
- Develop a high-performing organization through coaching, talent development, and performance management
- Create an inclusive environment embodying Company Values and Enterprise Leadership Skills
- Collaborate cross-functionally with Quality, Technical Operations, Engineering, Validation, Supply Chain, and Regulatory partners
Requirements
What you’ll need- Bachelor’s degree in science, Engineering or another technical field
- Minimum 3 years of leadership experience within Manufacturing, Quality, Technical Operations, Engineering, Validation, Supply Chain, or related life science operations
- Demonstrated experience working in a regulated GMP environment
- Proven experience leading teams and delivering results through others
- Strong knowledge of current Good Manufacturing Practice regulations, Good Documentation Practices, and quality systems
- Demonstrated experience supporting investigations of manufacturing events, deviations, non-conformances, audits, and operational issues
- Ability to identify systemic issues, assess risk, and implement effective corrective actions
- Experience working across Quality, Manufacturing, Engineering, and Technical Operations organizations
- 2 or more years’ experience in aseptic or sterile manufacturing operations preferred
- Experience supporting FDA, EMA, or other global regulatory inspections preferred
- Experience with Quality Management Systems, including deviations, corrective and preventative actions, change controls, and audit responses preferred
- Experience supporting teams through compliance-related challenges, regulatory feedback, or inspection readiness activities preferred
- Knowledge of Company Production System, visual management, and structured problem solving preferred
- Experience using operational excellence and Lean methodologies to improve performance preferred
- Strong understanding of data integrity and quality culture expectations preferred
- Required skills include Biochemical Analysis, Clinical Manufacturing, Dosage Forms, Evaluating New Technologies, Identifying Customer Needs, Medical Knowledge, New Product Research, Patent Commercialization, People Leadership, Pharmaceutical Production, Pharmaceutical Technologies, Pilot Plant Operations, Specification Development, and Team Leadership
- US and Puerto Rico residents only
- No visa sponsorship
- Valid driving license is not required
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Relocation: No relocation
