QA Manager and QP in Bracknell

At Sandoz, our Purpose is pioneering access for patients. Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

The purpose of the role is to perform duties of the Qualified Person in compliance with all applicable GMP regulations and directives. Provide leadership of compliant and efficient quality processes to support GxP activities at the Country Organisation meeting internal and external stakeholder requirements. Streamline and improve quality processes, facilitate quality management and lead the development of a right first time, quality culture.

Your Key Responsibilities:

• Leading local execution of quality systems including compliance to GxP requirements, 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 participate in expert networks or work with Centres of Excellence.
• Perform routine risk/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.
• Investigate, manage and actively resolve quality investigations as needed e.g. deviations, complaints, CAPA at the country organisation.
• Gain expert knowledge of IT platforms/applications supporting quality systems.
• Ensure efficient information flow and effective communication of all relevant quality matters within the country organisation.
• Develop and recommend changes for productivity and quality improvements.
• Lead in implementation of quality initiatives & continuous improvements.
• Perform tasks related to quality compliance/governance depending on individual experience.
• Work with the country organisation business 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.
• Support and development of personnel in Sandoz Quality team using Capability Assessment and MyGrowth tools.
• Resource planning with the team with responsibility to ensure personnel are trained to undertake GxP activities.
• Conduct batch assessment and release activities, in a timely manner, and meeting relevant regulatory standards.
• Lead activities supporting batch release, ensuring oversight of the Quality System.
• Maintain knowledge in accordance with the Qualified Person’s Code of Practice.

What you’ll bring to the role:

• Life science degree level or equivalent experience.
• Eligibility as Qualified Person ideally with experience of multiple dosage forms.
• Over 5 years experience in the pharmaceutical industry, GxP knowledge.
• Detailed knowledge of GMDP requirements relating to manufacturing, packaging, licensing, release and post-market responsibilities.
• Knowledge of process improvement techniques.
• Good working knowledge of problem solving and evaluation techniques.
• Development of quality systems and/or processes.
• Coaching/training/facilitation skills.
• Good level of skills in the use of computer based systems and applications.
• Interpersonal relationships and collaboration.
• Good communication skills to ensure information is taken, used and given at all levels for maximum benefit to the business.
• Operational Excellence (includes problem solving & continuous improvement).
• Being resilient, motivated, managing multiple priorities.
• Organisation of own and team workload – self-directed and able to flex to meet peaks in workload.

You’ll receive:

• Competitive salary
• Annual bonus
• Pension scheme
• Health insurance
• 24 days annual leave
• Flexible working arrangements
• Employee recognition scheme
• Learning and development opportunities

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health. With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported! Join us, help us make healthcare fairer and faster.

Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Skills Desired: Quality Decision Making, Quality Management, Stakeholder Management, Teamwork.