Pharma QA Manager: Compliance & Final Release

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

Benefits offered by this job

401(k) with company match

Medical, Vision and Dental insurance

Health Savings Account (HSA)

Paid time off

Job summary

Fagron is seeking a Quality Assurance Director to direct all QA functions for validation, training and documentation. You will partner with Corporate Quality to ensure the site complies with regulatory and corporate requirements and will be responsible for final product release.

You will lead a team of Pharmacists, interact with FDA/DEA, oversee validation, deviation investigations, CAPA, and continuous improvement initiatives to keep manufacturing in full cGMP compliance.

Qualifications

• Bachelor's degree with a minimum of 5 years related work experience including a minimum of 3 years of supervisory experience.
• 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

• Direct QA validation, training and documentation control functions.
• Oversee team of Pharmacists performing final product release.
• Interact with Regulatory Agencies including FDA and DEA.
• Drive CAPA items to completion and monitor deviation investigations.
• Provide cGMP guidance to all departments engaged in production of pharmaceutical products.

Skills

Supervisory experience

Regulatory compliance (cGMP/GLP)

Regulatory inspections

Quality systems knowledge

Communication skills

CAPA management

Education

Bachelor of Science Degree

Advanced degree preferred

Tools

Lotus Notes

Microsoft Word

Microsoft Excel

Job description

Fagron is seeking a Quality Assurance Director to direct all QA functions for validation, training and documentation. You will partner with Corporate Quality to ensure the site complies with regulatory and corporate requirements and will be responsible for final product release.

You will lead a team of Pharmacists, interact with FDA/DEA, oversee validation, deviation investigations, CAPA, and continuous improvement initiatives to keep manufacturing in full cGMP compliance.