Senior Manager

2 months ago


Leeds, United Kingdom MAC Clinical Research Full time

MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.
We have an exciting opportunity for a Production Manager to join our busy GMP Team in Leeds, West Yorkshire.

Hiring managers are looking for candidates who preferably have a strong knowledge of GMP, the ability to plan and execute complex projects and experience of working with graded manufacturing suites. Named as the “Production Manager” on the MHRA MIA (IMP) licence.
To be responsible for the leading, delivery and evaluation of comprehensive production services including aseptic services.
Responsible for training of production staff.
To liaise with staff including the Medical Director, PI (Principal Investigator), Sub- Investigators, Site Directors, Project Managers and CTAs, regarding requirements for studies of Investigational Medicinal Product (IMP) / commercial and comparator
To liaise with sponsors, vendors and customers for pharmacy production queries and guidance.

Strong knowledge of Good Manufacturing Practice
~ Familiar in working in Graded Manufacturing Suites
~Clinical trials manufacturing experience would be beneficial but not expected.
~ Great organisational skills and the ability to manage projects.
~ Knowledge and experience with Quality Management Systems
~ In lieu of Academic qualifications extensive experience would be expected.


Ensure compliance of Manufacturing Unit with EU GMP
Ensure that products are produced and stored according to the appropriate documentation so that they reach the appropriate standards of quality
Approving the instructions relating to production operations and ensure their strict implementation
Ensuring that the production records are evaluated and signed by an authorised person before they are sent to Quality Control (QC) Department
Ensuring that the required initial and continuing training of their department personnel is carried out and adapted according to need
The monitoring and control of the manufacturing environment,
Ensure plant hygiene standards are maintained
The approval and monitoring of suppliers of materials
The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activates
The designation and monitoring of storage condition of materials and products
The monitoring of compliance with the requirements of good manufacturing practice
The inspection, investigation, and taking of samples, to monitor factors which may affect product quality
Participation in management reviews of processes performance, product quality and of the quality management system and advocating continual improvement
Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management
Compliance with MAC health and Safety policy
Compliance with MAC policy on equality and diversity
To maintain professional qualifications required for the role, including continuous personal development
PHYSICAL, WORK ENVIRONMENT, TRAVEL DEMANDS:
Required to travel to individual MAC Research sites as appropriate for training, equipment issues and client visits.
Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
~ Health Insurance
~ Free onsite parking
~25 days annual leave (increasing in increments to 30 days after 6 years' service)
~ Your birthday off work



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