A Career with Purpose
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.
At Bionical Emas, you will have the chance to develop your career while working with an outstanding team of people. Our shared values create a unique culture that guides our actions and defines who we are. You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging. We believe that creating opportunities for our people to develop their skills is crucial to our growth and success. If you are inspired by changing the lives of patients all over the world, we’d love to hear from you.
About the Role
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 UK operates under two authorisations; the Manufacturers Specials Licence (MS) and the Wholesale Distributors Authorisation (WDA), in accordance with the requirements set out in the Human Medicines regulations 2012. This role formally fulfils the duties and activities of the Responsible Person (RP) and the Responsible Person for import (RPi) as detailed within the WDA.
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.
What will your job look like?
* 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
* Reviews and approves deviations and changes related to GMP and GDP operations
* Ensures qualification of vendors and suppliers involved in the GMP and GDP supply chain
* Manages Product Quality Complaints resulting from product supply/use
* Coordinates Internal Audit/Self Inspection program for GDP operations
* Qualifies critical equipment, systems, and processes supporting GDP operations
* 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
* Advocates for continuous improvement and maintains effective CAPA programs
* Manages Quality Technical Agreements, importation processes, and product supply/release for unlicensed medicines
* Conducts GDP Vendor and Supplier audits and oversees customer qualification processes
* Fulfills formal duties of Responsible Person and Responsible Person for Import as per WDA
* 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
What will you need to succeed?
* 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
* Wide knowledge of products & processes used in the distribution & manufacture of licensed and unlicensed medicines would be advantageous
* Recent experience of, and knowledge of, working within MHRA licence requirements would be advantageous
* Hands-on approach, with a ‘can do’ attitude
* Previous line management experience would be advantageous
What will you get in return?
We want you to do your best work! We care about our people’s well-being, their personal development and providing a true work-life balance. Our benefits are aligned with our culture and values and are intended to maximize your experience working for us. Here are some of the benefits you can expect from working for Bionical Emas.
* 25 days of vacation
* 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
Does this sound like you?
It is time to apply, and we can’t wait to hear from you!
Even if you don't meet 100% of the requirements, be confident in yourself and don't hesitate to apply!
PLEASE NOTE: We will be longlisting applications as soon as we receive them, so please apply early to register your interest
We Are Bionical Emas
We are proud of our people and proud of our achievements. We encourage and hire people with diverse backgrounds, voices, beliefs, and perspectives into our growing global workforce. 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 HR@bionicalemas.com.
We Are Bionical Emas, where each person is unique. We celebrate individuality while encouraging our talents to work as a team. Together, we make a difference by powering an inclusive future for all. Be you, with us.
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. Our Privacy Notice explains what personal information we may process, where we may process your personal information, our purposes for processing your personal information, and the rights you can exercise over Bionical Emas’ use of your personal information. By applying for the above position, you confirm that you have reviewed and agreed to our Data Privacy Notice for Candidates: Privacy Policy - Bionical Emasapplicable to your place of residence.
Powering the patient journey
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