Senior Pharma QA & Compliance Leader

Fagron Tech; Canton (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

401(k) plan with company matching

Medical, vision and dental

Health savings account (HSA)

Holiday/paid time off

Job summary

Fagron US in Canton, MA is seeking a QA leader to direct all quality assurance functions, including validation, training and documentation, ensuring product release in compliance with regulatory standards. The role collaborates with Corporate Quality and regulatory agencies such as FDA/DEA.

You will supervise pharmacists, manage quality systems, CAPA, deviations, and continuous improvement. A BS with 5+ years in QA with supervisory experience and strong GMP/GLP knowledge is required; advanced

Qualifications

• Bachelor of Science Degree with a minimum of 5 years related work experience including a minimum of 3 years of supervisory experience. Advanced degree strongly preferred.
• Position requires advanced training or experience in cGMPs and GLPs.
• Ability to understand and interpret federal regulations and company operating procedures as they apply to medically complex adverse drug events and determine whether the events suggest a product quality issue.
• Ability to interpret large amounts of safety and quality-related data and recognize/identify potential health hazards (signal detection).
• Must be able to prioritize and multi-task with minimal supervision.
• Knowledge of PC systems and Microsoft Office Suite (Word, Excel) required. Lotus Notes experience preferred.
• Excellent written and verbal communication skills.
• A very strong working knowledge of regulatory requirements and ISO requirements in the parenteral pharmaceutical industry as well as other legal requirements for business operations.

Responsibilities

• Responsible for administration of Compounding Quality Assurance and Compliance to assure timely delivery of results to manage the company objectives and production as well as new product introduction on time.
• Reviews procedures of quality systems, validation, change control, manufacturing discrepancy investigations, cGMP/regulatory compliance, and product specifications.
• Participates in regulatory inspections of the compounding facility.
• Responsible for the team of Pharmacists performing the final product release.
• Works independently of direct supervision, but interacts with all levels within the site organization and with corporate quality functions on a regular basis.
• Routinely interacts with Regulatory Agencies including, but not limited to, FDA and DEA.
• This position directly manages the validation, training and documentation control functions. It has indirect (dotted line) responsibility for QA interpretations of Quality problems in QC.
• Administers, reviews, and approves corporate policies related to standard operating procedures, validation documentation, and manufacturing discrepancy reports.
• Provides cGMP guidance to all departments engaged in the production of pharmaceutical products.
• Responsible to ensure all deviation investigations are appropriately investigated and recorded. Drive CAPA items to complete and timely completion.
• Assumes responsibilities for the daily functional activities and has authority to make decisions for the facility QA department in internal and external meetings.
• Assumes responsibilities for major projects, such as new products or facility renovations. Actively participates in and supports Continuous Improvement initiatives.
• Manages the administration of the Quality system in the Quality Organization. Develops personnel, administers budget, plan for future resource needs with regard to personnel, equipment, and facility.
• Directs investigations of product complaints for manufactured products and completion of appropriate documentation. Interacts with the US regional Medical Affairs and Vigilance Department as needed.
• Participates in Regulatory/FDA inspections by providing information or expediting/obtaining information required by the inspectors.
• Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required.
• Develops employees to better accomplish and perform in their duties as quality professionals.

Skills

Communication skills

Leadership

Quality systems knowledge

Regulatory compliance

GxP experience

Education

Bachelor of Science Degree

5+ years QA + supervision

Tools

MS Office

Lotus Notes

Job description

Fagron US in Canton, MA is seeking a QA leader to direct all quality assurance functions, including validation, training and documentation, ensuring product release in compliance with regulatory standards. The role collaborates with Corporate Quality and regulatory agencies such as FDA/DEA.

You will supervise pharmacists, manage quality systems, CAPA, deviations, and continuous improvement. A BS with 5+ years in QA with supervisory experience and strong GMP/GLP knowledge is required; advanced