PURPOSE & SCOPE OF THE POSITION
The Head of Quality Control contributes to developing Symbiosis’ mutually beneficial relationships by:
- Leading the Quality Control function to deliver all QC activities and continuously develop new strategies to maximise performance and service levels.
- Managing personnel, resource and maintain inspection readiness for Manufacturing Authorisations maintained by Symbiosis.
- Educated to a degree level in Life Sciences.
- Knowledge of EU GMP requirements including requirements for all EU GMP Chapters, and Annexes 1, 2, 8, 9, 13, 15, 16 and 19
- Knowledge of FDA guidance for industry and CFRs
- Knowledge of ICH Guidelines including ICH Q2, Q9, Q10, Q5
- Knowledge of EU GMP and US FDA for Advanced Therapy Medicinal Products
- Experience in Quality Control Testing at a senior or management level including analytical, microbial, bio-analytical and biological methods
- Experience in microbial testing within a cGMP environment including product testing and facility environmental control / management
- Experience in a GMP manufacturing environment supporting quality control responsibilities for clinical medicinal products
- Experience in supporting or leading regulatory inspections
- Experience in a service company and with a very strong client orientation
- Experience in service company for commercialised/licensed medicinal products
- Experience in a cGMP manufacturing environment supporting quality control responsibilities for commercial medicinal products
- Demonstrated leadership role with quality control function
- Effective communication skills
- Flexible and adaptive team player
- Ability to perform multiple tasks effectively in a busy environment
- Ability to lead and support key activities and priorities within a cross-functional team
- Experience in assuming delegated role of senior quality management
If you would like to apply for this role, please send your CV and cover letter, detailing your salary requirements to firstname.lastname@example.org
Operational Quality Control
- Lead the management and approval of all Technical Agreements in relation to Manufacturing, Testing and Stability Programmes.
- Ensure implementation of stability study management as per the appropriate agreements.
- Maintaining contract testing organisation management including but not limited to all testing related issues, supplier reviews, appropriate quality technical agreements and reference and retain sample control.
- In collaboration with the Manufacturing Management team support and monitor facility environmental monitoring including reporting and trending of data.
- Ensure appropriate management and implementation of QC data bases to support business requirements.
- Management and approval of sampling plans for in-process and finished Lead the develop, monitor, improve and maintain procedures to ensure compliance with Good Manufacturing Practice (EU/FDA and other appropriate standards) for the manufacture and testing of pharmaceuticals.
- Ensure all testing is carried out, review and approved by the QC department as per the approved technical agreement and results are approved against the appropriate specification.
- Develop and maintain specifications, sampling procedures, testing methods (including validation and transfers).
- Support the COO and BD teams in new business development opportunities evaluating and supporting discussions/review around quality control testing.
- Lead batch certification duties in accordance with relevant procedures and provide support to the Quality Assurance and Qualified Person for GMP Compliance and Certification.
- Collaborate with Quality Assurance, Quality Systems, technical and supply chain departments manager to ensure materials from external suppliers meet quality requirements as defined by EU/FDA/EP/USP or other appropriate standards.
- Lead the development, implementation and subsequent monitoring of continuous improvement activities.
- Provide QC coaching/guidance for cross functional groups to ensure compliance.
- Co-ordinate and provide training across functional groups in Quality Control procedures, cGMP requirements and QC concepts.
- Ensure provision of QC support to management during third party audits, regulatory inspections and Client audits.
- Act as main point of contact for contract testing facility to support test management and control.
- Lead department training and personnel development including QC related procedures and concepts as directed by the COO and wiser Senior Management Team.
- Ensure facility contamination control is maintained and overseen as per the requirements of EU GMP and other appropriate regulations.
- product testing
QMS and Compliance
- Lead investigations and report quality issues including non-conformances (NCR), out of specifications (OOS), out of trends (OOT) and environmental monitoring excursion (EME) investigations, escalating to senior management as required.
- Facilitate Quality Assurance with supplier management for Contract Testing and Storage Facilities
- Review and issue of new and/or revised SOP’s
- Management and reporting of Internal and External Audits
- Management and reporting on Quality Review meetings – specific data for QC department.
- Ensuring compliant implementation of documentation management within the quality control function and systems
- Support the management of existing and emerging Quality initiatives.
- Represent the company to external customers, authorities, and service providers when required.
- As part of the Quality team, I contribute to the business performance as agreed based on the informed advice of Quality and regulatory requirements.
- Ensure relevant Quality Control processes, procedures, are harmonised across the company.
- Support and (if appropriate) deputies for the Head of Quality Assurance and Head of Quality Systems.
- Contribute to the generation of the Quality Control budget.
- Subsequently, manage the departmental budget.
Management & Development of Team
- Demonstrate and actively foster the work ethic, culture, and values of the Symbiosis and the Quality team.
- Implement clear communication formats which supports client projects and service levels.
- Support the recruitment, induction, management and development of Quality Control staff to ensure they are clear about how they contribute to Symbiosis and can operate at their best.
- Understand my team’s needs, capabilities and preferred ways of working, provide them with agreed support and feedback and help them to remove any barriers to them performing at their best to enhance their contribution to the role and improve productivity.
- Attend, lead, participate and contribute to regular staff meetings, as necessary.
- Invest in developing relationships with all staff to fully understand staff needs and develop our people strategies accordingly.
- Invest in developing relationships with the management team to ensure we are a high performing team and Symbiosis’ services meet expectations.
- Act as an ambassador for the company.