Reporting to Director Quality and Commercial Operations. Works in the Quality Group within the Technical Operations department, which oversees contract manufacturing operations, supply chain operations and development functions as well as internal Quality Systems .Has oversight of Quality Assurance aspects of Company products, internal quality systems and development projects. Responsible for performing key Quality tasks in respect of Company products and development projects.
Responsible for developing and maintaining Quality Systems and Vendor Management activities to ensure that all operations are fully in compliance with current international standards for cGMP.
- Manage the GxP vendor qualification programme including initial and ongoing qualification to ensure quality oversight of GxP Vendors.
- Act as lead auditor in third party vendor audits, to include: GMP contract manufacturing, analytical testing, and storage locations; GCP clinical sites and associated vendors; Pharmacovigilance and GLP sites when required.
- Maintain appropriate Quality or Technical agreements with all GxP vendors
- Be a key member of company audit team during regulatory or customer audits. Ensure a state of constant readiness for unannounced regulatory inspections.
- Support the execution of the internal Quality Management System (QMS) to ensure compliance to all relevant standards within the company, including, but not limited to Product Complaints, Deviation & CAPA, Out-of-Specification Investigations, Change Control, Product release for distribution, Internal Audit, SOPs and Controlled Documents, Training, Artwork approval, Validation and qualification
- Contribute to the development of quality policies and procedures and participate in the internal audit programme, which serves to verify adherence to and compliance with the requirements set out in these controlled documents.
- Design and implement quality metrics and quality systems and reporting on performance thereof, including annual product quality review
- Provide QA and technical support to key company pre-and post-approval development activities such as: Manufacturing site transfers and process scale-up; Product life cycle maintenance activities and new product launch; Analytical method qualification & method transfer; Integration activities following product acquisition and Product formulation development.
- Review or author CMC documents which may be included in regulatory submissions e.g. annual reports, stability reports, supplements
- Build authentic relationships and lead business meetings and audits of critical suppliers and contract manufacturers and maintain all product-related Quality Technical Agreements (QTA’s).
- Participate in and provide critical analysis of business diligence visits
- Work closely with other members of Technical Operations group to ensure delivery of key project objectives and timelines
- Work directly with other key Company departments to ensure compliance and productive working relationships.
- Assist with troubleshooting quality issues at Partner’s or vendor’s site or associated with technology transfer, when required.
- Integrate, contribute, and/or lead cross-functional project teams as required. Support projects schedules as required.
- Foster a positive employee relations environment and a culture of continuous improvement and teamwork through the use of good and consistent management principles.
- Bachelor’s degree in chemistry, biology, pharmacy or a related discipline. An advanced degree in pharmaceutical science desirable.
- Significant experience (5-10 years) working in pharmaceutical industry. Experience should be in the quality assurance, quality control, development, and/or manufacturing areas.
- Thorough understanding of Quality Systems and cGMPs.
- Experience with and fundamental understanding of FDA / EMA regulations, associated guidance documents and in interfacing with regulatory bodies or working on regulatory submissions
- Experience in the following desirable: finished product manufacturing, particularly sterile product manufacture; analytical method development or executing analytical methods and process validation and/or IT compliance
- Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, partners and colleagues.
- Experience working with contract manufacturing organisations
Other Skills, Personal Competencies:
- Highly organised, with exceptional time management and prioritisation
- Critical thinking and evaluation of process problems
- Excellent verbal and written communication skills
- Patient and results focused
- Good Leader and highly motivated.
- Collaborative team player
- Strong work ethic with a flexible and adaptable approach.