Quality Manager
Sandoz
full-time
Posted on:
Location Type: Office
Location: Bracknell • 🇬🇧 United Kingdom
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Leading local execution of quality systems including compliance to GxP requirements (requiring knowledge of regulations – MHRA and HPRA), global standards/SOP’s and local work practices.
- Responsibility for monitoring compliance of the quality activities/systems owned locally, including metrics, quality review and self-inspection.
- Liaise with global quality system owner and where appropriate participate in expert networks or work with Centres of Excellence.
- Perform routine risk and impact evaluations associated with product-based decisions or the quality system and participate in escalation situations.
- Ensure local compliance with global standards/SOP’s and maintain relevant local SOP’s.
- Communicate requirements and/or changes and act as content expert for audits and inspections using knowledge of associated systems.
- Investigate, manage and actively resolve quality investigations as needed e.g. deviations, complaints, CAPA at the country organisation (where necessary in conjunction with nominated third parties) to minimise impact on product availability and sales.
- Ensure efficient information flow and effective communication of all relevant quality matters within the country organisation, from the country to the Global QA organization and vice versa including but not limited to issue escalation.
- Develop and recommend changes for productivity and quality improvements.
- Lead in implementation of quality initiatives & continuous improvements including project planning, milestone delivery and communication within the team and cross functionally.
- Perform tasks related to quality compliance/governance depending on individual experience. This could involve product launch evaluations, product divestments, quality oversight, MAH responsibilities, regulatory updates, development of documents such as site master file or business continuity plan, metrics review, quarterly leadership presentations or acting as a single point of contact for e-compliance, data integrity, document management.
- Work with the country organisation business franchises/brands to provide direction and support for all quality / GMP matters.
- Provide GxP education and training to others in the team and across the CO.
- Setting and review of objectives using the Evolve process.
- To personally fulfil the duties of the Responsible person defined by UK/Ireland Health Authority, including ensuring GDP operational activities are maintained and continuously improved in accordance with internal guidance and external regulations (MHRA/HPRA), maintaining awareness of legislation and Sandoz Quality System, overseeing activities in the event of a product Recall, and understanding the role of professional bodies such as GPhC and the Home Office in relation to handling of controlled drugs.
Requirements
- 5 years’ experience in the pharmaceutical industry, GxP knowledge.
- Life science degree level or equivalent experience.
- Experience of line manager responsibilities.
- Detailed knowledge of GMDP requirements relating to manufacturing, packaging, licensing, release and post market responsibilities.
- Development of quality systems and/or processes, including knowledge of process improvement, problem solving and evaluation techniques.
- Demonstrated technical and GDP knowledge and experience to fulfil duties of RP.
- Relevant knowledge and experience related to the distribution of medicinal products; products traded under the license and access to pharmaceutical knowledge and advice when it is required.
- Interpersonal relationships and collaboration.
- Good communication skills to ensure information is taken, used and given at all levels for maximum benefit to the business.
- Being resilient, motivated and can manage multiple priorities.
Benefits
- Competitive salary
- Annual bonus
- 24 days annual leave
- Flexible working arrangements
- Employee recognition scheme
- Learning and development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GxP knowledgequality systems developmentprocess improvementproblem solvingrisk evaluationquality complianceCAPAmetrics reviewGMDP requirementsdocument management
Soft skills
interpersonal relationshipscollaborationcommunication skillsresiliencemotivationpriority managementleadershipteam communicationcontent expertisechange management
Certifications
life science degreeResponsible Person certificationGPhC registrationMHRA compliance trainingHPRA compliance training