Quality Assurance Officer - Derby, Derbyshire, United Kingdom - Bionical Emas

Description

Bionical Emas is a global Clinical Research Organization (CRO) bringing life-changing medicines to patients around the world.

We combine Clinical Development, Clinical Trial Supply (CTS) and Early Access Programs (EAP) to deliver a unique, seamless service to our pharma and biotech clients.

You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging.

This individual will be joining tosupport the overall compliance and fitness for purpose of the Quality System that supports the UK operations of medicinal product sourcing, importation and distribution for Early Access Programs (EAP) and Clinical Trial Supplies (CTS).

The role incorporates the responsibility for line management of QA team members within the overall UK QA function.

As part of the broader QA team at Bionical Emas, the role requires engagement with internal and external stakeholders to promote quality in all activities and deliverables undertaken.

You will oversee the implementation, application, and maintenance of the Bionical Emas Global Pharmaceutical Quality System for the UK facility and operations
You will be required to write, review, and approve Policies and SOPs detailing quality and operational processes
Manages Product Quality Complaints resulting from product supply/use
Participates in global management review meetings to monitor QMS performance and emerging quality trends
Supports Quality Management Review activities both locally and globally
Incorporates Quality Risk Management principles into the Quality Management System
Leads hosting and management of GDP Regulatory Inspections and audit responses
Manages Quality Technical Agreements, importation processes, and product supply/release for unlicensed medicines
Provides management support for the UKQA GMDP team and collaborates with Business Unit Directors
Ensures development opportunities for the UKQA team and identifies training needs
Facilitates delivery of mandatory GDP training within QA and operational functions
Impressive, demonstrable track record & skills/experience gained within similar positions (including quality roles and covering GMP and GDP requirements)
Good understanding of the pharmaceutical industry, including the unlicensed medicines sector
Previous line management experience would be advantageous
We care about our people's well-being, their personal development and providing a true work-life balance. Vacation days purchasing scheme
~1 extra vacation day per each 3 years of service
~ Discretionary Annual Bonus
~ Sabbatical of 3 to 6 months (after 2 years of service)
~ Free food and beverages at all offices
~ Life Insurance
~ Health Insurance and Employee Assistance Programme
~ Employee Support Networks – help us continue to build on our inclusive culture
~ Flexible and hybrid work

We do not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state or local laws and ordinances.

Bionical Emas' management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment.

Bionical Emas offers equal opportunities and is committed to diversity in its workplace and providing accessibility accommodations to applicants with physical and/or mental disabilities.

If you are interested in applying for employment with Bionical Emas and need accommodation or special assistance, please let us know by sending an email with your request to the recruitment team at .Protecting your privacy and the security of your data is a longstanding top priority for us.

Please consult our Privacy Notice to know more about how we collect, use, and transfer the personal data of our candidates.

By applying for the above position, you confirm that you have reviewed and agreed to our Data Privacy Notice for Candidates:
Privacy Policy - Bionical Emas applicable to your place of residence.