Based at the Edinburgh BioQuarter, RoslinCT is a leading Contract Manufacturing and Development organisation within the cellular therapies/ATMPs field, performing cutting edge investigational medicinal product manufacture for clinical trials across Europe and the US.
The Company is now embarking on an exciting period of planned growth, and we are recruiting for some key operational roles to help support and lead that growth into the future, including this one.
We are searching for a Quality Control Manager to join our expanding team and manage the Quality Control requirements of the company, ensuring compliance with GMP, HTA and MHRA legislations.
Candidates for this role must also be able to demonstrate a strong commitment to our Core Values, and so should be:
* Passionate about Customer Satisfaction
* Able to support a ‘one team’ approach
* A great communicator
* Committed to personal growth and development
* Accountable for their work
This role of Quality Control Manager will report directly to the Senior Leadership Team and will be responsible for managing all aspects of our QC practices, with the key aims of ensuring that all ATMPs and stem cell lines produced by RoslinCT are quality controlled to comply with the requirements of GMP, and to co-ordinate and oversee the microbiological monitoring of our expanding GMP clean room manufacturing operations. You will take complete ownership of the development, co-ordination and senior technical support of our GMP QC operations.
Your responsibilities as QC Manager will vary but will include:
* To manage the analytical laboratories and delegating activities therein, whilst providing required staff support, ensuring that ATMPs and stem cell lines produced by RoslinCT are quality controlled and comply with the requirements of Good Manufacturing Practice (GMP).
* To undertake the Quality Control function within RoslinCT, ensure that sampling, and testing is performed against set specification in accordance with approved schedules prior to release of any product. In particular, the post holder will ensure the Quality Control compliance with the applicable HTA and MHRA regulations.
* Lead, motivate and develop Quality Control staff to ensure they deliver on goals and achieve appropriate standards of work, and to ensure that the training needs of the Quality Control team are identified and training is carried out and recorded.
* To review and approve the procedures relating to all Quality Control activities, including where these are out-sourced, to ensure their compliance with the relevant standard/guidelines.
* To develop and continually improve the awareness of Quality Control staff in the requirements of GMP and best practice for applying GMP to RoslinCT activities. Participate in RoslinCT management processes by membership of key management teams to ensure decision can be made on the basis of informed advice on issues of Quality Control.
* Ensure documentation, including SOPs and protocols are in place for all activities performed within Quality Control and these are reviewed regularly. Ensure effective planning and resource management to ensure the Quality Control function is organised and resourced to deliver.
* Work closely with other company departments to ensure Quality Control scheduling is aligned with manufacturing and other commitments.
* Ensure incidents or changes are documented and approved in accordance with approved procedures and that risk assessments are performed across all aspects of Quality Control. Ensure that equipment and processes used in the Quality Control department are subject to effective validation, and that documentation used is approved.
* Liaising with suppliers, new technology partners and contracted companies to continually improve the quality of materials necessary for QC Analytical work. Ensure excellence in customer service across all aspects of the QC Analytical department, including representing RoslinCT at conferences and hosting customers and regulators. Present and deliver external communication on behalf of RoslinCT.
* Manage 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.
* Lead in the recruitment of Quality Control, as required, and ensure that the department is adequately provided with trained, motivated staff who are able to meet all of the RoslinCT requirements.
The post holder will have;
* A degree in a Life Science subject, or equivalent qualification or experience is required. A relevant post graduate qualification would be desirable.
The ideal candidate will also have:
* Significant experience in a relevant area of activity (e.g. pharmaceutical industry/stem cell activities) in a supervisory/managerial role.
* A clear understanding of GMP and Quality Control and a thorough technical background in Analytical QC techniques including flow cytometry, tissue culture and molecular biology.
* Demonstrable leadership qualities, communication, interpersonal and motivational skills, ability to take decisions, ability 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).
Behavioural Attributes Required:
The ideal candidate will also demonstrate:
* Exceptional organisational and planning skills with the ability to plan ahead whilst delivering to deadline, with 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 skill and excellent administration and record keeping skills. Ability to learn and share knowledge with the management team and the wider team where appropriate, and excellent attention to detail.
* A determination to succeed, with a ‘can do attitude’, and to continually develop and improve standards. Ability to create a positive environment through self-awareness and social skills, take responsibility for setting high standards and look at the bigger picture to recognise the impact of actions.
* Emotional resilience and an ability to work under pressure with good humour.
Alongside a competitive salary you will receive:
* 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 where you are able to claim cash back towards dental check-ups and treatment, new glasses, contact lenses and therapy treatments such as physiotherapy and chiropody and more, in addition to the Employee Assistance Programme.
* 31 days annual leave with an extra day from 3 years’ service and a further day from 5 years’ service, plus 5 public holidays.
Location: Edinburgh BioQuarter. Please double check you can realistically commute to our site before applying
Product Quality Assurance
Coaching And Mentoring