Assoc. Dir., External Quality
USA - Pennsylvania - West Point, United States
Job Description
Position Overview - Basic Functions & Responsibility Essential function(s) includes, but is not limited to:
The incumbent is responsible for all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.
The incumbent also ensures that effective and robust Quality systems are followed to comply with required regulations, policies and guidelines governing the External manufacture of materials for the Company (e.g. small molecules, therapeutic proteins, biologics, vaccines, devices, combination products, sterile product, excipients, active pharmaceutical ingredients, intermediates, seeds and cell banks) through direct oversight, support and technical advice, counseling to site leadership, and on-site supervision. The AD may serve as a subject matter expert for EQA and Division in specific Quality systems, technology platforms, regulatory expectations and/or EE management, and can represent the Company in forums on their area of expertise (both internal & external).
Primary Activities
Primary activities include, but are not limited to:
May manage a team of Quality Assurance professions as direct reports. Holds regular 1-on-1 meetings and Employee Development Plan discussions.
Responsible for executing the performance management process including objectives setting, objectives approval, objectives revision, year-end accomplishment evaluation, and performance discussions with direct reports, when applicable.
Contributes to development of the EQA budget and tracks and controls expenses as needed to meet EQA budget.
Exhibits our company Leadership Behaviors and provides a leadership example for the team.
Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc) both domestic and foreign.
Maintains and provides expertise on EQA systems, tools, data, and processes on an ongoing basis.
Responsible for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
May support the interpretation and aggregation of financial/business data for EQA and highlight concerns as appropriate to EQA Management. Identifies and facilitates resolution of major deviations from financial or strategic plans. Coordinates the development, with the EQA Senior staff, of the EQA budget, Long Range Operating Plan, workforce planning, and other strategic activities as required. Analyzes headcount data to provide budget forecasts to management.
Responsibility for oversight of …
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Hybrid Hybrid work Hybrid work model On-site Puerto Rico residents only Travel required US and Puerto Rico residents only
Benefits/PerksBonus eligibility Diverse workplace Employee development Equal opportunity Equal opportunity employer Flexible work Flexible work arrangements Health Care Hybrid work Hybrid work model Inclusion Inclusive environment Insurance Meetings Paid holidays Retirement benefits Sick Days Vacation
Tasks- Budget development
- Coaching
- Communication
- Compliance
- Compliance assurance
- Data Analysis
- Distribution
- Documentation
- Innovation
- Leadership
- Performance management
- Planning
- Process Improvements
- Quality assurance
- Quality control
- Quality oversight
- Regulatory filings
- Serve as a subject matter expert
- Team Management
Aggregation Audit Audit readiness Batch Documentation Biologics Biology Biotechnology Budget management Cell Banks Change Control Chemical Chemical Engineering Chemistry Coaching Combination products Communication Complaint Management Compliance Continuous Improvement Controls Counseling Data Data analysis Development Deviation Investigation Deviations Distribution Documentation Education Employee Development Engineering English Evaluation GMP Health policy Inclusion Innovation Inspections Interpersonal Leadership Management Manufacturing Medical Medical device Metrics Microbiology Monitoring MS Negotiation Operations Organization Packaging Performance Management Pharmaceutical Pharmaceutical Industry Pharmacy Planning Policy Process Improvement Process improvements Quality Quality Assurance Quality Control Quality oversight Quality Systems Regulatory Regulatory Compliance Regulatory filings Regulatory inspections Regulatory requirements Relationship building Research Safety Science Small Molecules Supervision Team Leadership Technical Technology Testing Therapeutic proteins Vaccines Workforce Planning Writing
Experience5 years
EducationAS Biology Biotechnology Business Chemical Engineering Chemistry Degree Development Engineering English Equivalent Health Care Health Policy Management Microbiology MS Pharmacy Relevant experience Science Technology
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9