Director, Site Quality Head
il y a 2 semaines
In line with the Global Quality strategy, develops and leads the Quality Management department of the site to assure appropriate quality and compliance of all materials/products, operations, and services with relevant national, international and company specific laws, regulations and guidelines.
Leads and has the managerial responsibility ("is accountable") for all Quality Management functions at the site including Quality Assurance and Quality Control.
As a member of the Site Leadership Team (SLT) and the Global Viral Vector Service (VVS) Quality Leadership Team, contributes to the development and continuous improvement of global quality standards and practices, integrates those into the local Pharmaceutical Quality Management System, and ensures their successful implementation on site.
PRIMARY RESPONSIBILITIES
- Leads and ensures the successful daytoday operations of Quality Assurance and Quality Control departments in line with defined business needs and budgets.
- Ensures the success of the teams by oversight of the Sr. Managers, Managers, and Supervisors of the functional groups.
- Ensure the timely completion of all required departmental tasks to the appropriate internal and client specific standards.
- Establish meaningful goals and metrics for groups in conjunction with the SLT and the Global VVS Quality LT, and lead the performance to those goals
- Work with customers to ensure clear and open communication is maintained and challenges are effectively addressed.
- Define priorities and ensure that all work performed by staff is performed safely, with quality, and in a timely, manner.
- Lead and ensure department participates in continuous improvement projects throughout the group and the facility/operational portions of the organization.
- Leading, managing and/or participating in the investigation of nonconformances and followup corrective/preventative actions in compliance with quality procedures, policies, and regulations.
- Providing feedback and mentor in technical skill development, job performance, and career growth, and taking vital disciplinary actions if necessary. Advocating for employees when required.
- Ensure awareness and understanding of Quality principles and requirements across the site to assure that the entire site team acts consistently and appropriately.
- Maintain an independent authority for Quality owned decisions.
- Develop proactive and productive relationships with regulatory Authorities and Clients
How will you get here?
- Bachelor's degree in a Science Subject area
- 10+ years of proven record in a GMP environment
- 4+ years of prior successful experience in a Manager role is required.
- Performing in a contract manufacturing environment or managing contract businesses
Knowledge, Skills, Abilities
- Sterility assurance and contamination control.
- Technical knowledge of (bio)pharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management is desirable
- Strong interpersonal and communications skills; written and oral, and a validated ability to make key decisions.
- Proficient with computer (MS Office) and internet skills. Working knowledge of controlled documentation and data systems.
- Continuous improvement mentality.
- Assertive, not aggressive, assurance of quality throughout all operations within the facility. The ability to constructively work with colleagues when a Quality concern is in conflict with shortterm business desires to optimally conclude the issue at hand to the best business advantage (both short
- Able to work with the goals and objectives and translate them into concrete work for staff to meet.
- Able to build and maintain highly functioning teams, cohesive, striving for common and individual goals, in a positive atmosphere for all employees. Able to coach and mentor more junior employees to success.
- Actively takes the lead in ensuring GMP compliance for the company. Sets strategy in investigations and CAPAs.
- Communicates with contractors and internal manufacturing/technical groups regarding compliance and quality issues (i.e., batch documentation, investigations, timelines and data related issues).
- Able to lead performance.
- Drive the Quality Team in establishing and maintaining adequate and sustainable quality and compliance level in accordance with Thermo Fisher standards, regulatory guidelines and GXP compliance requirements, also through a proper management and constant monitoring of the Quality organization in place.
RELATIONS:
Internal
- All company functions at all levels
- Other Thermo Fisher Scientific production sites
- SLT
- Global VVS Quality LT
External
- Clients
- Suppliers
- Health authorities
- Other Regulation Entities
Languages:
- French
- English
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