Quality Control Manager

RoslinCT is looking for a driven individual to join us as QC Manager - Analytical Operations.

We are a world-leading contract manufacturing and development organisation, specialising in the field of cellular therapies, advanced therapeutic medicinal products and regenerative medicine.

We perform cutting edge therapy discovery and manufacture with a focus on stem cell therapies for clinical trials across Europe and the US. We have embarked on an exciting period of growth and are now recruiting across all our teams to support our expansion. This position of QC Manager - Analytical forms a key part of that growth.

The Role:
Reporting to the COO, you will join the rapidly expanding QC team to manage all aspects of our Analytical molecular biology operations. The ideal candidate will have a thorough technical background in Analytical molecular biology techniques and an excellent understanding and proven track record of working effectively in a GMP QC laboratory in a supervisory/managerial role.

Responsibilities:
You will be responsible for the development, co-ordination and senior technical support of our GMP QC Analytical operations ensuring compliance with necessary regulations through scheduling of timely product releases and supervision of a growing team of Analytical staff. To this end, your responsibilities will be varied but will include;
• Managing the analytical laboratories and delegating activities therein, whilst providing required staff support.
• Identification and support of training needs of all direct reports, ensuring training and competence of all personnel carrying out analytical activities. Lead, motivate and develop Quality Control staff to ensure they deliver on goals and achieve appropriate standards of work.
• Support for continuous development of an enthusiastic and collaborative Analytical team, to promote continuous process improvements throughout company.
• Development and continuous improvement of the awareness of Quality Control staff in the requirements of GMP and best practice for applying GMP to RoslinCT activities.
• Review and approval of procedures relating to all Quality Control activities to ensure their compliance with the relevant standard/guidelines.
• Participation in RoslinCT management processes by membership of key management teams to ensure decisions can be made on the basis of informed advice on issues of Quality Control.
• Completion and review of GMP documentation within the QC department including, qualification/validation, Incident Reports, Change Controls and Risk Assessments.
• Ensuring that equipment and processes used in the Quality Control department are subject to effective validation, and that documentation used is approved, and that equipment is maintained, qualified and Calibrated in accordance with agreed timelines.
• Management of documented procedures for ensuring all raw materials used for manufacturing are checked against agreed specifications and are only released for use after appropriate inspection procedures.
• Identification, evaluation of feasibility and introduction of new technologies to the department.
• Liaising with suppliers, new technology partners and contracted companies to continually improve the quality of materials necessary for QC Analytical work.
• Promotion and maintenance of company performance standards and operational excellence.
• Day to day management of the QC Analytical Laboratories to ensure effective and safe operation.
• Ensuring excellence in customer service across all aspects of the QC Analytical department, including representing RoslinCT at conferences and hosting customers and regulators.
• Recruitment of innovative scientists and professionals to grow the team, in addition to devising training plans and carrying out regular performance reviews.

Values:
A key part of working at RoslinCT is being able to embody our company values, which are integral to the work we do here. As such, you should be able to demonstrate:
• Passion for customer satisfaction
• Ability to support a ‘one team’ approach
• Great communication
• Commitment to personal growth and development
• Accountability for your work

Qualifications:
The ideal candidate will hold a degree in a Life Science subject or equivalent relevant experience. A relevant post graduate qualification would be desirable.

Skills and Experience:
The ideal candidate will demonstrate:
• An excellent understanding and proven track record of working effectively in a GMP Quality Control laboratory in a supervisory/managerial role.
• A thorough technical background in Analytical techniques including flow cytometry, tissue culture and molecular biology.
• Demonstrable leadership qualities, communication, interpersonal and motivational skills.
• Demonstrable ability to take decisions, to analyse information in a logical manner and to prepare coherent investigative and/or technical reports.
• Demonstrate competence in reporting and presenting internally/externally (MHRA visits, customer visits).

Behaviours:
The ideal candidate should also be able to demonstrate:
• Exceptional organisational and planning skills with the ability to plan ahead whilst delivering to deadline.
• Excellent communication and interpersonal skills and a proven track record in maintaining effective relationships and working with a wide range of people.
• Excellent oral and written communication skills; able to explain technical or complex concepts in a clear format.
• Proven logic and decision making abilities, critical thinking skills.
• Excellent administration and record keeping skills.
• Ability to learn and share knowledge with the management team and the wider team where appropriate.
• Excellent attention to detail.
• A determination to succeed, with a ‘can do attitude’
• A determination to continually develop and improve standards.
• Ability to create a positive environment through self-awareness and social skills.
• Ability to take responsibility for setting high standards and looks at the bigger picture to recognise the impact of actions.
• Emotional resilience and an ability to work under pressure with good humour.

Benefits:
In addition to a competitive salary and the opportunity to join an exciting, rapidly expanding company delivering life-changing therapies, we can offer:
• Group Personal Pension Plan: 3% Employee contribution with an Employer contribution of initially 5% for the first year of joining the scheme then a 1% increase per year until a maximum of 8% is reached.
• Group Life Cover, 3X Salary.
• Health4All Cash Plan: Claim cash back towards dental check-ups and treatment, new glasses, contact lenses and therapy treatments such as physiotherapy and chiropody and more.
• Employee Assistance Programme.
• 31 days annual leave with an extra day from 3 years’ service and a further day from 5 years’ service.
• 4 days public holidays leave.
Location:
We are based at Edinburgh BioQuarter, which acts as a hub for Scottish Life Science with close links to the University and the Royal Infirmary.