Manager, Operations

at  Thermo Fisher Scientific

JOB DESCRIPTION

Are you ready to take the next step in your career in pharmaceutical manufacturing? We have an exciting opportunity for Operations Manager as part of our sterile pharmaceutical manufacturing team at Swindon. This is an opportunity where someone can make a real difference working at the heart of operations on site. This could be an ideal role for someone to expand upon their current manufacturing and leadership experience and join us a complex, dynamic and continuously improving pharmaceutical manufacturing environment!

QUALIFICATIONS/EXPERIENCE:

• Experience of bulk manufacturing and filling within medium to large scale pharmaceutical manufacturing.
• Deep understanding of regulations surrounding Good Manufacturing Practice across UK, Europe and USA, preferably with experience of manufacturing sterile drug and implementation of UK/EU GMP Annex I
• 5 years leadership experience in a Pharmaceutical/Healthcare environment (preferably within manufacturing, quality, or engineering).
• Preferably qualified to degree level in Science or Engineering (or a related field).
• Proven track record of making sound risk-based decisions in line with internal and external quality standards
  Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

This role is for an Operations Manager for bulking and filling of commercial sterile pharmaceutical products in compliance with company quality regulations, and external regulatory expectations and delivering On Time, In Full (OTIF) to customers with a Right First Time (RFT) approach. An essential part of the role will involve developing, inspiring, and leading productions teams, supporting continuous improvement and contributing to the overall performance of the site. This role works in close collaboration with Quality Assurance, Technical Support, Engineering, Supply Chain, Technical Transfer, Quality Control and Business Management.

Leadership/ People Management: Support development of team members and ensure their understanding of individual contribution. Act as role model for leadership capabilities, safety and quality compliance.

• Lead, manage and develop team members using regular informal feedback, 121s and performance management and development programme considering technical, pharmaceutical, financial and business aspects.
• Ensure manufacturing plans are detailed and aligned to meet delivery targets, identifying and coordinating resolution activities as required
• Review manufacturing downtime trends, determine solutions and implement strategies to reduce downtime
• Drive operations related projects for completion on time and in budget
• Deputize for Senior Operations Manager if required.
• Represent the organisational values in discussions with colleagues, clients, auditors and inspectors.

GMP/ Compliance and Ethical Conduct: Ensure compliance of self and others to standards and regulations through working in alignment with processes and procedures

• Prioritise and supervise allocation of workload associated with quality records
• Coordinate, write and review deviation investigations utilising root cause analysis tools to enable effective and robust Corrective Actions/Preventative Actions to prevent recurrence
• Identify staff training and development needs
• Conduct self-inspections and maintain a state of audit readiness within operations

Lean & Continuous Improvement: Proactively look for opportunities to drive continuous improvement (Practical Process Improvement), influence decisions and deliver the results

• Work with site leadership team to develop metrics and identify appropriate targets.
• Cascade and communicate to the teams through the varied communication channels (visual managment boards, handovers, tiered accountability huddles, 121s, team meetings, PMDs) to support a strong understanding of targets, and foster a desire to achieve and exceed. Trend and report team performance to targets.
• Develop tools for strategic improvements within operations and supervise progress against metrics by implementing Practical Process Improvement (perform Gembas of processes, contribute to Kaizens and Root Cause Counter Measure workshops, complete Just Do It actions, collaborate with other departments on cross-functional projects)
• Role model and champion 5S and lean manufacturing principles

Safety, Health & Environment: Promote an environment of safety and wellbeing of self, others and environment.

• Understand and ensure implementation of emergency procedures and safe systems of work.
• Ensure compliance with environment, health and safety rules, signage and instructions
• Ensure prompt reporting and investigation of all accidents, near misses and identified hazards