QA Lead - GMP Compliance

at  Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.
We employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
The Role
We have an exciting role available for Quality Assurance Lead - GMP Compliance at our site in Alnwick, Northumberland.
Working with the Senior Director, Compliance and Quality Assurance team, you will ensure GMP activities at the site are conducted in accordance with current regulations, standards, company policies and procedures. You will Support the provision and development of the site Quality System. This role offers plenty of opportunities for continuous improvement and future progression to leadership.

Main tasks and responsibilities

• To own the development and delivery of GMP training programs, including but not limited to
• GMP Basic principles
• Initial GMP Training
• Refresher GMP Training
• Specialised GMP Training (in conjunction with functional experts)
• To track and trend quality metrics and work with the Senior Director, Compliance and Operations Leadership Team to address areas of poor performance.
• To own and improve GMP document control processes.
• To oversee various QMS processes including CAPAs, risk management, change control, internal/external auditing, supplier management, etc.
• To assist the QA team with the planning, conduct, reporting and follow up of internal, client and supplier audits.
• To provide QA oversight on continuous improvement initiatives and work collaboratively to promote continuous improvement of the QMS.
• Involvement in regulatory inspections as required.
• To comply & adhere to guidelines and regulations as required of this role.

Qualifications and experience required for competent performance

• Minimum 5 years’ experience in a GMP QA role within the pharmaceutical or related industries.
• Hands-on experience of overseeing Quality Management System compliance and proven track record of delivering quality systems improvements.
• Experience of working with steriles manufacture strongly preferred.
• Leadership and Management experience preferred.
• We are looking for someone with self-awareness who can adapt to working with different teams and personalities. Confident, collaborative and respectable when working with others.
• Strong communication skills.
• Ability to multitask and work to deadlines

Application Requirements
When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.
Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.
This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination

• To own the development and delivery of GMP training programs, including but not limited to
• GMP Basic principles
• Initial GMP Training
• Refresher GMP Training
• Specialised GMP Training (in conjunction with functional experts)
• To track and trend quality metrics and work with the Senior Director, Compliance and Operations Leadership Team to address areas of poor performance.
• To own and improve GMP document control processes.
• To oversee various QMS processes including CAPAs, risk management, change control, internal/external auditing, supplier management, etc.
• To assist the QA team with the planning, conduct, reporting and follow up of internal, client and supplier audits.
• To provide QA oversight on continuous improvement initiatives and work collaboratively to promote continuous improvement of the QMS.
• Involvement in regulatory inspections as required.
• To comply & adhere to guidelines and regulations as required of this role