Quality Systems Manager

Protak Scientific
We are the world exclusive manufacturer of Enzymatic Biological Indicators (EI's) for rapid decontamination
process validation for the pharmaceutical and healthcare sectors. Having invested multi millions into product
development and global introduction, we are now rapidly growing and see significant growth. We already hold
ISO9001 registration and have developed a substantial QMS. Due to changes within the company we have a need
to appoint a highly experienced Quality Systems Manager.

Overall Purpose of the Role:
Develop and sustain the Quality Management System in line with the required industry standards (including:
ISO9001, ISO13485), accreditation requirements and business requirements across the organisation through
existing and new procedures. Regulate, control and improve the quality of all processes throughout the business
and the final product. Manage the audit program to ensure that all nonconformities raised from certification
bodies, customers or against suppliers during audits are effectively corrected and independently verified. Embed
a culture of continuous improvement throughout the company. Lead the team to achieve quality management
system targets for customers and business goals.

Key Responsibilities:
Strategy and Development

• Contribute to the creation and implementation of best practice Quality strategy, policies, processesand procedures to aid and improve operational performance.
• Lead and manage certification for ISO 13485.
• Contribute to new business initiatives and projects and review and communicate the impact on
• Quality Management Systems (QMS).

General and Task Management

• Develop the Quality Management Systems strategy and KPIs, demonstrating solid progress against plans and objectives.
• Manage all external registration requirements to ensure they are met. Liaise with external bodies on all matters relating to registration. Maintain and improve, in line with business needs.
• Implement all relevant procedures described in the Quality Management System (QMS).
• Ensure that all in-house systems and procedures are updated, revised and modified to meet the needs of external certification bodies whilst ensuring simplicity and understanding for their use.
• Train others in all aspects of the quality system and application of procedures.
• Undertake regular internal/external process audits of the QMS.
• Ensure corrective actions are undertaken to address non conformities found.
• Verify and ensure timely closure of non-conformities.
• Ensure ongoing compliance with the Quality Management System (ISO9001).
• Embed and ensure suitable risk management processes are in place for the business.
• Introduce new systems and procedures where appropriate.
• Motivate and coach the team to operational success, both in terms of quality delivery and customer satisfaction.
• Work as part of the Management team to share ideas and improve operation, recommending, supporting and implementing continuous improvement activities and process and procedure improvements to optimise results.

Self-Management:

• Comply with the Health, Safety and Environmental Policies.
• Anticipates and overcomes obstacles.
• Makes useful links to arrive at insightful plans and solutions.
• Embraces personal challenge.
• Confident, rounded thinking.
• Takes ownership for team cohesion and team development.
• Is self aware.
• Is resilient, optimistic and open to change.
• Has a collaborative approach to others.
• A self-starter, motivated and able to positively motivate others.
• Focused, target driven with a positive, can-do attitude.

Skills and Attributes:

• Excellent influencing skills ensuring content of discussions are factual, thoughtful and conclusion/resolution based.
• Ability to manage a variety of cross-functional team members.
• Excellent written, verbal and presentation skills.
• Excellent organisational and follow-up skills.
• Competent in problem solving, team building, planning and decision making.
• Commercially aware.

Qualifications and Experience Levels:

• Relevant pharmaceutical related degree is preferred, or HND, BTec Professional Level 5 Award or equivalent NVQ Level 5 qualifications.
• Significant experience in an aseptic pharmaceutical production / manufacturing environment is key.
• Experience of H202 gaseous decontamination processes advantageous and desirable.
• Strong knowledge of Pharmaceutical manufacturing/Medial device quality management.
• Experience in conducting QMS related audits. ISO 9001 Lead Auditor Training accreditation Advantageous and desirable.
• Previous experience and involvement in Regulatory Audit control processes (facilitation, hosting and presenting).
• Experience of dealing with customers and suppliers.