A Career with Purpose

Bionical Emas is a global Early Access Programs (EAP) and Clinical Trial Supply (CTS) group bringing life-changing medicines to patients around the world. Their range of services and capabilities benefit many of the world’s leading pharma and biotech companies.

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

We are looking for a Senior QA Office who will be responsible for supporting the implementation and maintenance of the company Quality Management System (QMS), in relation to the Importation, Storage and Distribution of Pharmaceutical products to support Clinical Trials Supply (CTS).

The role is accountable for ensuring compliance with Good Distribution Practices (GDP), for those operations undertaken against the Wholesale Distributor Authorisation (WDA).

What will your job look like?

• Provide Quality input to CTS business set-up meetings, new programs and initiatives, and pre-approve/approve Company transactions in compliance with relevant jurisdictions (MHRA/FDA/EMA) and applicable licences.

• Support RPi release documentation for UK-imported product, and work with the Responsible Person on final disposition of returned, rejected, recalled or falsified products, including coordinating responses to recall notifications from Competent Authorities or manufacturers.

• Create, review and approve quality documentation as required — including quality statements, Pedigree Statements, declarations, SOPs/WIs, controlled documents, and Technical & Quality Agreements (prior to final RP approval), ensuring QTAs are implemented and reviewed within appropriate timescales.

• Qualify customers and supply chain entities to receive/supply medicinal products (including licence verification and questionnaires), and maintain QA lists including the ASL, AVL and CTS Client and Delivery Site List.

• Support the implementation and maintenance of the Quality Management System, ensuring all manufacturing and distribution activities comply with QMS requirements and controlled documents are reviewed and re-issued within defined periods.

• Ensure GMDP training requirements are met across all personnel, including management of the LMS (SOPs, quizzes, training records) and training matrices, and provide training and support across functional groups as directed by QA management.

• Raise, review, manage and drive to timely closure all Quality System records — Non-conformances, Complaints, CAPAs and Change Controls — including root cause analysis, design and effectiveness verification of pragmatic CAPAs, and sharing of KPIs, metrics and trend analysis with senior management.

• Support audits and inspections: assist with preparation, hosting and management of Client, Customer and Competent Authority audits/inspections, present QMS performance where required, and coordinate QA responses to client questionnaires, RFIs and RFPs.

• Coordinate the internal and external audit schedules, performing internal self-inspections and external supplier/vendor audits as required.

• Drive continuous improvement of the QA function in collaboration with the Quality Manager — including QMS performance reporting for Quality Management Review, generation of ICH Q9-based risk assessments, undertaking delegated RP duties, and deputising for the QA Manager when required (with appropriate training).

What will you need to succeed?

• A scientific degree would be ideal

• Impressive, demonstrable track record & skills/experience gained within similar positions, including quality roles and covering GDP requirements

• Previous experience in pharmaceutical industry

• Wide knowledge of products & processes used in the distribution & supply of medicines for Clinical Trials

• Working Knowledge of Good Distribution Practice of medicinal products for human use (UK medicines Regulations and EU Directive 2013/C 343/01, Green guide – rules and guidance for pharmaceutical distributors)

• Recent experience of, and knowledge of, working within MHRA licence requirements

• Ability to mentor/ train junior staff

• Hands-on approach, with a ‘can do’ attitude

• An openness to technology and new ways of working

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 Emas applicable to your place of residence.

Powering the patient journey