Quality Site Head

Fagron Nederland BV; Canton (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

Life insurance

Paid holidays

Paid time off

401K with company match

Employee assistance program

Flexible working arrangements

Job summary

Fagron US in Canton, MA, seeks a Quality Site Head to own the quality systems and regulatory compliance for a 175-person facility. You will oversee QA/QC, investigations, CAPAs, and change controls to ensure final product safety and efficacy for FDA and state boards.

You will lead audits, trainings, and regulatory interactions, while guiding budgeting and team development to maintain top-tier GMP standards and ongoing improvements.

Qualifications

• Bachelor's degree in science or pharmacy, with strong GMP knowledge.
• 10+ years in QA/QC roles within sterile pharma settings.
• Experience leading audits by FDA or equivalent bodies.
• Proven ability to design, implement and sustain QMS.

Responsibilities

• Oversee QA and QC at the Canton facility, including release, investigations, CAPA and deviations.
• Lead regulatory inspections and customer audits, and coordinate responses.
• Direct training, equipment validation, environmental monitoring, and calibration programs.
• Manage budgets, resources, and direct reports with strategic planning.
• Ensure compliance with cGMP, ISO 14644 and related regulatory requirements.
• Develop metrics, prepare reports, and drive continuous improvement initiatives.

Skills

Leadership

Regulatory knowledge

Quality systems

People management

Education

Bachelor of Science or Bachelor of Pharmacy

Advanced degree preferred

Job description

About the job

Quality Site Head for the 503B Outsourcing facility in Canton, MA of approximately 175 personnel. Responsible for the overall maintenance and continuous improvement of Quality Systems so that they are compliant for Federal (FDA) and State (Board of Pharmacy) regulatory organizations.

Oversees Quality Assurance activities, including incoming and final product release, complaint management, data management, calibration and validation requirements, conducting investigations and managing change controls and other activities as required to contribute to the assurance that final product is fit for use. Oversee Quality Control requirements, including analytical contract laboratory, microbiological and environmental testing as well as general lab maintenance activities. Oversee Training to ensure that all facility staff are trained in department specific activities, Quality Systems, SOPs and Good Manufacturing Practice, as relevant to their role. Responsible for leading company management reviews as well as inspections and other Regulatory and compliance activities.

Key Responsibilities

• Oversee all Quality matters at the facility, such as disposition of incoming materials and final product, review and acceptance of Quality control analytical and microbiological testing, completion of Environmental monitoring activities, management of Quality systems for deviations, change controls and CAPAs, validation and maintenance of equipment, quality support of clean room activities, training development and maintenance, and general Quality compliance activities.
• Participate in budget planning, including project, personnel and equipment estimations.
• Manage and develop direct reports through workload planning and prioritization, leadership, guidance and open communication.
• Ensure compliance with all relevant cGMP and corporate Quality System requirements.
• Has authority to make decisions for the QA and QC departments in internal and external meetings. Plans for resources and administrates Quality budget, with regards to personnel, equipment, and facilities.
• Ensure all Deviations, Excursions and OOS situations at the facility are properly investigated, have appropriate corrective actions and are closed in a timely manner.
• Leadership of Regulatory/FDA inspections and customer audits by providing information or expediting/obtaining information required by the inspectors/auditors, and follow-ups where corrective action is required.
• Participate in the scheduling, performance and response to internal and external inspections and audits.
• Directs investigations of product complaints and manufacturing discrepancies for manufactured products and ensures completion of appropriate documentation.
• Interacts with Pharmacists and Regulatory as needed.
• Supports human resources to better accomplish and develop personnel as professional quality managers, supervisors, and technicians.
• Ensures coordination of the monthly/quarterly metrics / KPIs for the site, as well as preparation, review, and approval of the semi-annual FDA product reporting and Annual Product Quality Reports.
• Participate in meetings with customer management, prepare and present reports on quality metrics and compounding center performance.
• Explore, evaluate and implement new technologies and/or procedures that optimize the technical performance and efficiency of the facility.
• Ensure all documentation is in compliance with company and regulatory requirements.
• Complete all required reports and administrative tasks within designated timeframes, including, expenses, etc.
• Maintain current knowledge of topics relevant to role and to the business, and US and International standards through attendance at seminars, lectures, meetings and professional conferences

Set yourself apart

• Maintain knowledge of technological advancements in areas relevant to role, including, clean room technology and specialized instrumentation.
• Maintain up-to-date knowledge of industry trends, cutting-edge practices and techniques, current publications, and regulations relevant to role and business.
• Maintain up-to-date knowledge of SOPs and policies and ensure compliance at all times.
• Understand internal and external customer issues and requirements.
• Ensure all Company related activities comply with relevant Acts, legal demands and ethical standards at all times.

Basic Qualifications

• Bachelor of Science or Bachelor of Pharmacy degree required, advanced degree strongly preferred.
• A minimum of 10 years work related experience including a minimum of 5 years as a manager of
• QC and QA functions in a sterile pharmaceutical manufacturing facility.
• Extensive understanding of IV drugs and aseptic compounding practices.
• Experience with FDA (or equivalent) audits and compliance including leading the audit process.
• Training in quality systems and an understanding of compounding center design and operations.
• Extensive knowledge of FDA GMP and ISO 14644
• Extensive experience and knowledge of GMP quality and operations will be considered in lieu of formal management responsibility.

Core Competencies

• Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and senior management.
• Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted.
• Strong attention to detail and focus on quality, accuracy, and accountability.

What's on offer?

We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success. Our benefits include, but are not limited to:

• Competitive Salary
• Health, Vision, and Dental Insurance
• Company Paid Life Insurance
• Generous Paid Holidays
• Paid Volunteer Time
• Generous Paid Time Off and Rollover
• Company matching 401K and Retirement Savings Plans
• Employee Assistance Program
• Flexible working arrangements

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. Fagron US is proud to be an affirmative action and equal opportunity employer.