Operations compliance lead - manufacturing

Operations Compliance Lead - Manufacturing


Operations Compliance Lead - Manufacturing

Direct message the job poster from Cpl Life Sciences


Managing Consultant @ Cpl Life Sciences | Life Sciences Specialist /Regulatory Affairs & Quality

Job Title: Operations Compliance Lead - Manufacturing

Job Type: Permanent, full-time - may include shift work

Location: Shoreditch, London, UK (On Site)

Cpl Life Sciences is collaborating with a growing biotech company that is focused on genetic therapies for both rare and prevalent diseases.

A new permanent position is available in the Manufacturing Operations team as an Operations compliance lead. You will be responsible for developing, managing and improving systems that drive excellent performance across a balanced scorecard of safety, quality, service, cost, improvement, and people within the Manufacturing organisation.

Major Activities

* Responsible for compliance and delivery systems management within manufacturing, including but not limited to:
* GMP Document flow for batch release -BMRs, forms, Logbooks, Protocols etc.
* MIAFs
* Tracking and completion of walkround and internal observations, outcomes/actions
* Responsible for performance monitoring, trending, and KPI management for documentation and GMP compliance activities within Manufacturing
* Project management and delivery of improvements to the manufacturing process, procedures, and ways of working
* Support overall progress of internal investigations into manufacturing deviations and safety incidents, and lead where appropriate.
* Process document updates and revisions e.g. SOP, BMRs WI etc.
* Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
* Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP-compliant manner before the task is undertaken
* Responsible for ensuring that any GMP documentation is closed timely and in a RFT state

Key Performance Indicators

* On time delivery of manufacturing system outputs e.g. BMR sign sign off
* On time closure of GMP compliance records within own area of responsibility e.g. (but not limited to) Issues, CAPAs, Change Controls & audit/inspection actions,
* Projects delivered to agreed schedules
* Quality performance of Manufacturing including compliance KPI and monitoring systems kept up to date
* Self-development and training
* Planning/Organizing - prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives
* Systems thinking – understands interrelationships between activities and systems and optimises ways of working to deliver the best overall results
* Data driven – highly proficient in acquiring, manipulating and analysing data to support performance improvement
* Problem Solving - Identifies and resolves problems in a timely manner; able to gather and analyze information; develops alternative solutions; works well in group problem solving situations
* Influencer – understands how to influence people with diverse backgrounds at different levels of the organisation to adopt better approaches consistently
* Change management – capable of planning and executing change in a way that people understand and adopt into their daily work
* Leadership - exhibits confidence in self and others
* Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence;
* Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
* Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
* Innovation - meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
* Oral Communication - speaks clearly; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
* Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.

Qualifications

* University degree or HNC/HND in Science or Engineering
* Experience in pharmaceutical product manufacture
* Background in manufacturing operations and quality systems
* Ability to work collaboratively with colleagues and peers from a range of functions and backgrounds in a results-driven, team-oriented environment
* Good understanding of GMP

For more information, please reach out to me at lucy.kirkaldy@cpl.com

You must be UK-based and have prior experience in a GMP environment.


Seniority level

* Seniority level

Mid-Senior level


Employment type

* Employment type

Full-time


Job function

* Job function

Quality Assurance and Engineering
* Industries

Biotechnology Research and Pharmaceutical Manufacturing

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