SUMMARY OF POSITION:
Lead and be responsible for overseeing all QA (Ops QA, Quality Support and Q/V) & QC efforts & GMP activities within the LEO Pharma Vernouillet site.
Responsible for all aspects of GMP Quality Assurance, including developing operating philosophies, establishment and maintenance of the LEO Pharma Quality Culture and establishing quality systems in alignment with LEO Pharma Global Standards and international GMP regulations.
- Directly lead and manage the Quality Support, Qualification & Validation, Operational Quality (Batch Review & Batch Release) & Quality Control departments
- Lead the GMP compliance efforts for all production process related to site
- Promote LEO Pharma culture of quality and continuous improvement across the organization
- Monitor and audit manufacturing for GMP compliance and serve as a key contact to operations regarding quality and compliance issues.
- Develop, manage, and maintain appropriate procedures to ensure regulatory compliance
- Establish and maintain key quality indicator elements, organize quality goals and objectives
- Identify, assess and incorporate best demonstrated industry practices to assure GMP and regulatory compliance with all relevant Health Authorities (HA) and applicable external regulatory requirements and applicable guidance documents
- Assure that Quality Systems are managed and continuously reviewed and improved for regulatory compliance and operating efficiencies
- Manage any third parties to which functions have been outsourced
- Promote and communicate the LEO Pharma Quality Plan and all associated policies and guidelines
- Maintaining a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements
- Improving operational performance of QA and QC departments by coaching team members
- Manage and support all HA and other regulatory agency activities including inspections, inquiries, notifications, all and other agency associated activities.
- Apply modern principles of quality systems and strategic planning to products and processes to achieve sustainable quality and compliance performance
- Establish and/or improve monitoring measures for key elements related to quality goal attainment
- Analyze and report product and process quality trends, and quality system integrity against internal and external guidelines, standards and regulations
- Develop and conduct training for quality and other personnel, as necessary. Ensure that quality department personnel are trained to perform their jobs effectively and ensure an efficient operation that is well integrated.
- Recognize need for investigation due to deviation from written procedures, conduct investigation into non-conformance, incidents/deviations and recommend disposition of the affected product/component
- Prepare trend reports related to in-process monitoring, deviation reports, investigation reports. Follow up with functional department for timely completion of corrective and preventive actions recommended
- Define/Perform annual and random audits
- Recommend continuous improvement plans based on observation of process, vendors, data, etc. to management.
- Ensure timely in-process/final testing of drug products.
- Notify any problems with in-process testing results to production immediately and investigate the incident, as appropriate.
- Maintain a thorough knowledge of appropriate standard operating procedures and applicable regulatory requirements and guidance documents.
- Perform personnel evaluation as needed.
- Develop and manage to the financial budgets for overhead and staffing
- Perform other related duties as assigned from time to time based on company needs
- The SGH will be part of the Site Leadership Team (SLT)
- The SQH is also the “Pharmacien Délégué” of the site (For Vernouillet only)
- Doctor of Pharmacy (Pharm. D.) with 10 to 15 years’ experience in a Sterile (Asepting filing) Drug Product/Pharmaceutical Quality Assurance/Quality Control environment. Five (5) years of progressive leadership or supervisory experience in a Quality Assurance function of the sterile pharmaceutical industry required.
- Being able to be registered as “Pharmacien Délégué” of the site – Section B of the “Ordre des pharmaciens” (For Vernouillet only)
- Industry Knowledge:
- Knowledge and experience of applicable regulatory standards and requirements for the Drug Products manufacturing required – EU and US FDA…
- Knowledge of analysis of DP utilizing UPLC/HPLC, GC, spectroscopic and wet chemistry techniques & microbiology.
- Preferred Skills:
- Demonstrated ability to implement continuous improvement methods to improve quality and operations performance. Six Sigma / Lean experience or qualification an advantage.
- 5-10 years relevant supervisory/management experience within a Quality function of healthcare/ pharmaceutical industry
- Advance level of written and verbal communication skills with the ability to read, technical procedures or governmental regulations.
- Excellent verbal and written communication skills. Ability to write reports and required documentations.
- Ability to communicate information with courtesy and tact
- Experience in computer applications such as SAP, Minitab, Microsoft Word, Excel, Access and Power Point.
- Highly self-motivated
- Strong organizational & presentation skills
- Initiative and mature judgement
- Accuracy and attention to detail and completeness of tasks
- Reasoning Ability:
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
- Supervisory Controls:
- Effectively manage competing priorities, adaptable to change, demonstrated ability to accept additional responsibilities and manage tasks through teamwork.
- Demonstrated abilities to provide direction to employees, establishes the overall objectives and resources available, broadly defines missions and functions to the employees.
- Assures that finished work and methods used are technically accurate and in compliance with established guidelines and procedures.
- Summary of Core Competencies:
- WW/EU/USA Drug Products regulatory compliance & GMPs, GMP Quality Assurance, QA, good manufacturing practices, auditing, inspection hosting, packaging, Quality Operations, Quality Control, plant floor, Operational Excellence/Continuous Improvements QA team leadership, batch record review, batch release, product disposition.
- Reports to Vice President, Global Quality with dotted line responsibility to Site Head.
- As “Pharmacien Délégué” of the site, reports as well to the “Pharmacien Responsable” (Only for Vernouillet)
- Frequent communication and working relationships with Sector manufacturing facilities and other LEO Pharma sites.
- Contact with regulatory authorities during inspections
- Located in Vernouillet (France)
- Occasional travel will be required for professional training seminars and conferences
- Ocassional travel will be required for off-site business meetings
PRESENTATION OF THE COMPANY :
- Founded in 1908, LEO Pharma is a pharmaceutical laboratory focused on research, whose headquarters are located in Ballerup near Copenhagen in Denmark. LEO Pharma is fully owned by a foundation, which guarantees it to be independent from the financial markets.
- LEO Pharma has developed over the decades world-renowned expertise in the fields of dermatology and thrombosis.
- LEO Pharma markets its products in more than 130 countries and employs around 5,200 people.
- Established on the national territory since 1958, LEO Pharma France, is today the first subsidiary of the LEO Group, with a turnover of about 500 M€.
- With around 600 employees (including 380 at the Vernouillet production site in Eure-et-Loir and more than 220 at the Voisins-le-Bretonneux headquarters and on a Medical Visit), LEO Pharma France is a responsible player in terms of employment in France.
- Established in Vernouillet since 1964 on almost 7,500 m², the LEO Pharma production site in France is at the forefront of current technologies, thus meeting international standards for quality and safety. This site specializes in the manufacture of injectable preparations (pre-filled syringes) and dry forms. He is the pilot and flagship of the Group because he produces Innohep® (Low Molecular Weight Heparin) for the whole world and thus exports 70% of its production.
- The Vernouillet site continues to grow in terms of production capacity and employees. The plant’s workforce has solidly grown from 166 people, to 330 in 2019. In the same period, investments represented € 59 million, and production capacity was multiplied by 4.
- The site is also certified ISO 14001 and OHSAS 18001.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.