Head of Quality Assurance - Canberra, Australia - Thermo Fisher Scientific
Description
Job Title:
Head of Quality Assurance
Reports to:
Site Head of Quality
Group / Division:
Pharma Services Group/ Drug Substance Division
Career Band: 8
Job Family:
Operations (OPS)
Job Sub Family:
Quality (Q)
Job Code:
OPS.QAOP.M08
Job Track:
Management
Position Location:
Australia
- Brisbane
- 37 Kent Street Woolloongabba
Number of Direct Reports:8
Position Summary:
Reporting directly to the Site Head of Quality, this position provides leadership, directs and leads the Quality Assurance organization and all Quality Assurance related programs and activities to support clinical and commercial manufacturing, testing, and release of biopharmaceutical products.
The Quality Assurance department is responsible for the development, implementation, auditing of and reporting on the status of the Quality Systems of the Thermo Fisher Scientific Brisbane, Australia site.
Further the QA and Quality Control tasks in relation to the manufacturing operations and batch disposition decisions. This position is a leadership position managing, developing, mentoring, and overseeing.The QA function, under the direction from the head of Quality, oversees the direct engagement of the site Quality department with the biopharmaceutical manufacturing process and is responsible to achieve and maintain compliance with all relevant national and international regulatory requirements and to thereby ensure the site's "Right to Operate".
Key Responsibilities:
Oversee and provide leadership to the Quality Assurance function.
Accountable for Quality Assurance oversight to ensure the corresponding phase appropriate cGMP compliance according to regulatory expectations.
Responsible for the effective implementation, monitoring and maintenance of the Pharmaceutical Quality System, ensuring the appropriate authorisation of written procedures and documents, the monitoring and control of the manufacturing environment, review/approval of relevant deviations, CAPAs, change controls and other quality system records and plant hygiene.
Responsible for ensuring that each batch of medicinal product has been manufactured and checked in compliance with the local/ regional/ national/ international laws in force and in accordance with requirements of the Marketing Authorisation, as required.
Initiate, lead and support improvement projects together with operational departments to address, prevent and reduce deviations
Fully collaborate with the Quality Audits Manager to host and lead internal and external audit/ inspections
Leads a team of managers and professionals within Quality: motivating, hiring and developing employees, assigns work, provides feedback, mentoring and coaching and taking disciplinary action when required.
Manages team performance through effective key performance indicators, targets and goal settings and provide this data to Site Leadership and the Global Quality organisation, as needed.
Supports the business development functions, providing appropriate Quality input to prospective customers, including the demonstration of compliance through audit.
Hiring, coaching and mentoring professional Quality staff
Advocate EH&S compliance
Complete any other legitimate duties requested by immediate manager.
Frequent Contacts:
Internal
- Operations
- Project Management/ Business Management
- Global Quality
- Regulatory Affairs
- Customers
- Health Authorities/ Regulatory Agencies
- Suppliers/ Vendors
Minimum Requirements/Qualifications:
Qualifications & Experience
- B.S. in a scientific/technical discipline with at least 5 years' experience in a Quality leadership role or a significant leadership position within the biological and/or pharmaceutical industry
- Demonstrated quality leadership for a Contract Manufacturer preferred.
- Confirmed operational leadership qualities within a commercial manufacturing setting
Skills & Attributes
- Determined, enthusiastic and driven
- A true leader and someone who has led transformational projects
- Strong management skills in order to manage and develop staff
- Must be able to handle ambiguity and to interact with and influence the most senior levels of the organization
- Dynamic leadership with a balance between Quality and business mindset
Other Job Requirements:
Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment
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