Lab Manager (OSD)

Basic qualifications: 

Bachelors degree (science)

Preferred qualifications: 

Lean Sigma Green or Black Belt

Details: 

Laboratory Manager (OSD)

We are a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing close to 100,000 people globally, we have 87 manufacturing sites around the world.
Our pharmaceuticals business researches, develops and makes available medicines that treat a variety of serious and chronic diseases. We have medicines available or in development in a wide range of areas including:

• infectious diseases 
• cancer 
• epilepsy 
• heart disease 
• asthma and chronic obstructive pulmonary disease 
• HIV/AIDS 

Ware Manufacturing Site:
Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form. The site holds a unique position in our network as the only site responsible for launching the company’s pipeline of new medicines in these dose forms, many of which are life saving medicines. A series of investments in new state-of-the-art equipment are being made that will support the delivery of a record number of new products. This must be achieved whilst consistently delivering outstanding quality, service and value to our patients.

Job Purpose:

The Quality Assurance Department within ensures that all aspects of the manufacture of products are performed in a controlled manner and meet commitments to international regulatory bodies as well as the requirements of current Good Manufacturing Practice.  

The laboratory teams working as part of the Site Value Streams will assure that manufactured products are compliant and fit for purpose.  This includes key activities:

• Product Analysis
• Laboratory investigations
• Trend analysis of analytical results.

The purpose of the role is to effectively manage, lead, and implement an effective long to midterm quality management plan for the sites laboratories to ensure the delivery of compliant product to our customers.

This includes: -

• Leading a multidisciplinary team of Quality Laboratory Analysts, Laboratory Team Leaders, Microbiologists and Compliance Leads.
• Testing and release of materials in line with Ware’s targets.
• Planning and fronting audits from regulatory bodies eg. FDA, MHRA
• Driving continuous improvement in compliance through the whole laboratory, to make step changes on Right the First Time.
• Proactive management of EHS performance in the laboratory.

Lab Managers will have an appreciation of the testing of raw materials, excipients, packaging materials, intermediate and final product, in addition to environmental and water testing. 

Key responsibilities:

Leadership
• Responsible for the effective and efficient day to day leadership of the laboratory and ensure lead times are adhered to and performance measures continuously improve.
• Develop local performance indicators to ensure all agreed performance measures are met. Eg Schedule Adherence & BNRFT
• Responsible for the recruitment, deployment, training, motivation, appraisal and development of laboratory staff.
• Plan the team’s activities on a 12 –18 month horizon
• Lead team meetings and briefings, enhancing team working and supporting team decisions
• Proactively manage HR activities and deal effectively with issues as they arise, including unplanned absence, performance management etc.
• Ensure resource plans are maintained and supported to enable QA targets to be met.
• Lead by example acting as a coach and mentor to team members
•  Introducing new technologies to the area they work in to improve efficiency whilst maintaining compliant.
• Ensures corporate computer systems (eg SAP, LIFT & Empower) are used effectively.
• Responsible for team members sharing knowledge and skills to allow team members to develop to their full potential.

• The role has a substantial planning and strategy focus.  Planning horizons are operationally in the 3-24 month horizon. Strategically, a plan will be developed to ensure all NPI requirements are completed for the laboratory.  This would be integral to the site wide plans

Compliance

• Act as an owner of key laboratory business processes including SOP and report author / authorizer.
• Ensure a Self-Inspection program is planned and delivered to ensure that the laboratories are inspection ready.
• Front and lead tours in Level 1,2,3 and 4 audits. 
• Leads internal audits and ensures all audit actions within agreed leadtimes.
• All laboratory documentation is maintained in continuous compliance with Company, local, regulatory and pharmacopeial requirements
• Responsible for safety of team members, ensuring that housekeeping is maintained, safety procedures are followed, risk assessments are completed and appropriate COSHH controls are used.

Continuous Improvement

• Leads continuous improvement activity to deliver cost reduction in Quality activities ensuring the change control process is appropriately used. 
• Drives the use of Operational Excellence (OE) toolkit to continuously improve operations ensuring quality standards are maintained.
• Dealing with increasing regulatory pressures, high level of change and technical complexity whilst driving continuous improvement and step change projects to achieve business plan targets.
• Challenging current ways of working, identifying and implementing improvement activities.
• Encourages the team to contribute ideas to new ways of working to improve systems in the laboratory.
• Seeks best practice and shares within the team and to a wider audience




Applicants must demonstrate in their application how they meet the above criteria in order to be successful for interview selection.

Closing date for applications: Friday 14 October 2016

When applying for this role, please use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.

Thank you for your interest in this opportunity.

Basic Education Required:
• Graduate in Science.
• Lean Sigma Green or Black Belt


Preferred Experience Required
• Full membership of a professional institute
• Broad experience with significant depth of the laboratory environment
• Excellent understanding of implementation of GMP in laboratory and manufacturing situations.
• Knowledge of Ware Value Streams from Suppliers to Customers.
• Detailed knowledge of regulatory guidelines eg ICH
• Good knowledge of Company Policies, e.g. Human Resources, Finance  Equal opportunities etc
• Knowledge of staff empowerment, team working , negotiation and motivational techniques
• Working knowledge of Company Law and legislation e.g. HASAWA, COSHH, 
• Knowledge of business requirements / strategy.
• Excellent communication skills at all levels
• Good understanding of all key technical aspects of the use of SAP/R3, LIFT, Empower etc.
• Leadership
• Strong interpersonal skills
• Ability to prioritise and delegate
• Team working
• Negotiation
• In depth knowledge of employee relations activities and including working in a unionised environment.
• Understanding of new technology best practice

Contact information: 

You may apply for this position online by selecting the Apply now button.