Quality Site Head

Fagron Genomics US; Canton (MA); Presencial; USD 150.000 - 190.000; Jornada completa

Descripción de la vacante

Fagron Genomics US in Canton, MA seeks a Quality Site Head to oversee QA/QC for a 503B outsourcing facility with ~175 staff. You will lead quality systems maintenance, deviations, CAPAs, and regulatory readiness to ensure products meet FDA and state standards.

You will direct audit readiness, investigator-led investigations, training, and management reviews, while coordinating KPIs and reporting to customers and management.

Formación

• 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.

Responsabilidades

• Oversee all Quality matters at the facility, such as disposition of incoming materials and final product, review and acceptance of QC 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

Conocimientos

Quality management

Regulatory compliance

Leadership

Attention to detail

Cross-functional collaboration

Educación

Bachelor of Science or Bachelor of Pharmacy

Advanced degree preferred

Herramientas

FDA audits experience

GMP knowledge

ISO 14644 knowledge

Descripción del empleo

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.