Associate Director, Quality Assurance
USA - New Jersey - Rahway, United States
Job Description
The Associate Director, Quality Assurance will be responsible maintain the clinical supply chain for sterile dosage drug product manufacturing at the Rahway, NJ site. This role will manage and execute GMP quality assurance activities directly related to internal and/or external sterile drug product production and batch release for clinical trial material supply. This role must assure that quality systems and controls for investigational new drugs (investigational medicinal products) meet all internal quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations.
Essential Duties and Responsibilities:
Act as Quality representative for internal or external manufacturing and testing of programs. Perform quality assurance activities for sterile drug product manufacturing in clinical development.
Ensure all drug products are manufactured in compliance with cGMP and regulatory filings. Ensure procedures are followed and specifications met to release or reject materials.
Review and approve batch production records, raw materials, intermediates, finished dosage forms; all related documentation, investigations, deviations, change records, etc. for each batch.
Review and approve quality investigations of events or non-conformances, complex and non-routine issues.
Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels.
Establish, educate, and enforce standard operating procedures required under GMP.
Participate or lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
Maintain a state of readiness for and participate in audits and inspections.
Represent the department or area on project teams or committees establishing GMP, or quality standards, policies or expectations within our company
On-site support of facility & staff (minimum 60% on a weekly basis)
Education Minimum Requirement:
Bachelor’s degree in a science, engineering, or related discipline; an advanced degree or certification in a management, technical, quality, or regulatory discipline will be preferred.
Required Experience, Knowledge, and Skills:
Minimum of 10 years of experience in Pharmaceutical or Biotechnology industry role(s).
Strong compliance knowledge and understanding of health authority regulations, and interpretation and application of GMPs within an R&D environment (i.e., apply the GMP Continuum).
Direct experience in GMP quality, operations, or laboratories. GMP experience at the interface between quality and either an internal manufacturing or laboratory function or external contract manufacturing, laboratory, or related operations.
Demonstrated experience with quality risk management.
Technical knowledge and understanding of manufacturing processes or unit operations for sterile or large molecule products, coupled with the ability to collaborate with subject matter …
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Hybrid Hybrid work Hybrid work model On-site Puerto Rico residents only US and Puerto Rico residents only
Benefits/PerksBonus eligibility Collaboration Diverse workplace Equal opportunity Equal opportunity employer Flexible work Flexible work arrangements Health Care Hybrid work Hybrid work model Inclusion Inclusive environment Insurance Paid holidays Retirement benefits Sick Days Teamwork Vacation
Tasks- Collaboration
- Communications
- Compliance
- Conduct quality investigations
- Conflict resolution
- Documentation
- Innovation
- Leadership
- Manage clinical supply chain
- Manage projects
- Participate in audits
- Participate in audits and inspections
- Process development
- Quality assurance
- Quality control
- Regulatory filings
- Risk Management
- Technology Transfer
- Validation
Analysis Analytical Analytical Testing Audits Biotechnology CGMP Change Control Cleaning Clinical Clinical Development Clinical Supply Clinical supply chain CMC Collaboration Commercial Communications Compliance Conflict Resolution Contract Manufacturing Controls Corrective Actions Cross-functional Teams Development Deviations Documentation Drug product Drug Product Manufacturing Education Engineering Equipment Facilities Management Formulation GMP Inclusion Innovation Inspections Interpersonal Laboratory Leadership Management Manufacturing Manufacturing operations Manufacturing processes Materials Management Operations Organization Pharmaceutical Preventive Actions Problem-solving Process Development Process Engineering Product Development Project Management Protocols Qualification Quality Quality Assurance Quality audits Quality Control Quality Engineering Quality investigations Quality Management Quality Management Systems Quality Risk Management Quality Standards Quality Systems R R&D Regulatory Regulatory Affairs Regulatory Compliance Regulatory filings Regulatory inspections Regulatory standards Research Risk Management Root Cause Analysis Scale-Up Science Standard Operating Procedures Supply chain Supply chain management Teams Teamwork Technical Technical knowledge Technology Technology Transfer Testing Validation
Experience10 years
EducationAdvanced degree AS Associate Bachelor Bachelor's degree Biotechnology Business Certification Communications Degree Development Engineering Health Care Management Regulatory affairs Related discipline Science Supply Chain Supply Chain Management 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