Associate Director, Quality Assurance

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 experts.

• Leadership of cross-functional teams, investigations, or problem-solving situations.

• Strong interpersonal skills including verbal and written communications, collaboration, teamwork within and across functions, conflict resolution.  Proven ability to work effectively with diverse teams and individuals.

• Demonstrated ability to manage projects and priorities, to meet deliverables and timelines.

Preferred Experience and Skills:

• Sterile dosage drug product (vial, syringe, other) manufacturing and/or analytical testing.

• A combination of experiences in quality assurance plus operations, laboratory, or related functional roles. Example functional roles include: quality operations, quality assurance, quality engineering, manufacturing, process engineering, product development, process development, materials management, supply chain management, quality control, analytical development, CMC regulatory affairs, equipment or facilities management.

• Diverse experiences in a GMP environment including but not limited to batch production record development, review, or approval, ancillary batch related records, standard operating procedures, work instructions, raw materials, deviations, change control, corrective actions, preventive actions, out of specification results, cleaning, validation plans or protocols, equipment qualification, audits, electronic inventory systems, quality management systems.

• Experience in manufacturing operations of ste