QA Manager

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

About The Job

Gives direction and manages all quality assurance functions of validation, training and documentation. Works with Corporate Quality as requested to assure the site operates in compliance with regulatory and corporate requirements. Responsible for final product release.

Key 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.

Basic 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.

What’s on Offer?

Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

At Fagron, you’ll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.

Ready For The Challenge?

We’re proud to be an equal opportunity employer. Diversity makes us stronger, and we’re committed to creating an inclusive workplace where everyone feels welcome.

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.