QA Director

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Company: Pharmasol
Location: South Easton, MA 02375

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Job Description

Pharmasol is a small to midsize privately held contract development and manufacturing organization (CDMO) of personal care and pharmaceutical products for prominent global brands and health care and cosmetics industries. We are driven by our strong management team, continuous improvement philosophy, and dedication to product quality, and customer service.

We currently have an opening for a Quality Assurance Director

Quality Assurance Director is responsible for ensuring that the company is in compliance with governing laws and regulations such as the FDA, European Union, Canada and other countries. The Quality Assurance Director works cross-functionally to assure that company-wide activities are performed and maintained in compliance with appropriate standards and regulations. This person will report to the Vice President of Quality Assurance to assure that all programs are appropriately staffed, quality-related project management deliverables are represented and reporting deliverables are met.

Core Responsibilities

  • Responsible for the overall quality system compliance of Pharmsol’s manufacturing operations and QC laboratory per requirements of 21 CFR 820 and 21 CFR 210/211.
  • Conduct quality control audits of production facilities verifying that company standards are maintained and product integrity is preserved.
  • Oversee plant quality by conducting and evaluating various tests of finished products, components and packaging.
  • Work closely with QC and Operations to support the timely shipment of products to customers.
  • Act as liaison for customers with various company departments regarding quality issues. Formulate and maintain quality standards for manufacturing and packaging processes, materials, and projects.
  • Educate and instruct plant personnel regarding quality assurance, process validation activities and change control.
  • Prepare monthly quality metric updates for review by executive management.
  • Develop, maintain, and conduct quality systems management reviews on a quarterly basis.
  • Ensure training of new personnel.
  • Administrative operation of the Preventative/Correction Action System as needed.
  • Support third party audits.
  • Own the various investigation processes such as CAPA.
  • Ensure documentation and controls are appropriate for organization.
  • Maintain Quality Assurance records.
  • Address non-conformities from internal and external audits.
  • Act as authority for product acceptance/rejection and release of goods.
  • Ensures that all quality related program deliverables are completed in a timely fashion
  • Own and administer the complaints handling program.

Preferred Qualifications:

  • Experience working in a regulated environment in compliance with 21 CFR 820, 21 CFR 210, 21 CFR 211
  • Minimum 8-10 years management experiences in a regulated industry
  • BS required in engineering, chemical engineering, chemistry or related sciences; MS preferred
  • Experience in establishing, maintaining and updating internal Quality policies, procedures and SOPs is an asset
  • Minimum of five years in a quality related position as well as five years in a project management position within the pharmaceutical industry
  • Proficiency with project management tools, techniques and processes
  • General knowledge of the requirements associated with GCP, GLP, GCLP and cGMP
  • Experience in supporting GCP, GLP, GCLP or cGMP operations in a pharmaceutical or pharmaceutical-support Company
  • Previous experience in supporting audit planning, execution and completion
  • Experience as a contributor/reviewer of technical protocols, data and final reports
  • Experience as a contributor/reviewer for regulatory documents
  • Experience in conducting risk assessment, root cause analyses, and impact analyses
  • Experience in people management, resource allocation, staffing strategies
  • Familiar with FDA guidance and quality systems
  • Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask
  • Excellent record keeping abilities to adequately document process development data
  • 10-15 years’ experience in Quality Assurance, Regulatory Affairs
  • International and Domestic Submissions experience with NDA, ANDA, PMA/510(k) devices

Pharmasol offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment. Pharmasol wants you to join their team and invites you to apply.

Job Type: Full-time

Job Type: Full-time

Work Location:

  • One location

Benefits:

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan
  • Flexible schedule
  • Professional development assistance

This Job Is:

  • A job for which military experienced candidates are encouraged to apply