Title: Associate Director, Quality (Aurora, IL)
Responsible for developing and administering the company’s Quality Assurance Program. Ensures that the quality assurance procedures and policies of the company are coordinated throughout the organization. Responsible for establishing testing policies and procedures for maintaining a program that will meet the quality assurance needs of the company.
- Directs and coordinates activities of QA to meet cGMPs and company’s quality policies and standards.
- Review and approve- master batch records, validation protocols and reports, cleaning validation/study protocols and reports, Stability protocols, Consumer product complaints, SOP’s, QC methods and specifications, annual product review, Quality investigation report, Laboratory investigation reports, Change controls, Equipment qualifications protocols and reports, Deviations, Labeling
- Monitors and reports on product quality performance and documentation performance.
- Review and release bio batches for clinical study
- Oversees the approval of objectives, policies and programs for company quality assurance activities and periodically evaluates results.
- Develops quality assurance plans; procedures and quality systems that will ensure production of finished products that meet specifications and cGMP standards.
- Reviews product defects and recommends modifications where warranted.
- Assists research and development and other departments as necessary in establishing new product standards prior to initial production.
- Provides assistance to the purchasing department in connection with the purchase of raw materials, supplies and equipment.
- Coordinates and directs inspection and in process testing of materials; intermediates; and drug products.
- Contacts customers and suppliers when necessary to confer on specific quality problems.
- Administers quality assurance budget preparation and other administrative functions to effect a well-integrated and efficient operation.
- Supplies technical assistance to the sales and/or marketing functions.
- Directs the continuing review of the quality assurance program and the formulation of new or revised procedures / quality systems to effect improvement and enhance efficiency.
- Ensures compliance with government regulations.
- Ensures all department personnel are qualified and trained to perform their jobs effectively.
- Provides cGMP plant wide training as needed.
- Prepares and improves SOP’s as required.
- Must participate and successfully complete all training as required by the company.
- Performs other duties as assigned.
Knowledge and Skills
- College degree in a science or engineering field, 10+ years of experience in pharmaceutical quality with broad knowledge of GMPs, solid and oral dosage forms, manufacturing and auditing, required
- Experience leading teams to improved performance demonstrated through metrics
- Prior management experience required.
- Must have excellent oral and written skills.
- Knowledgeable of cGMPs and regulations pertaining to quality system requirements for oral dosage forms, preferred
- Experience with quality systems, investigation writing, CAPA, preferred
- Experienced in conducting internal audits, and preparing for and hosting agency inspections and audits, preferred.