Qualification and Audit Programs Manager

Bionical Emas; United Kingdom; Hybrid; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Qualification and Audit Programs Manager to ensure compliance and drive quality assurance in the pharmaceutical sector. This role involves overseeing vendor qualifications, managing internal audit programs, and coordinating regulatory inspections. Join a supportive and flexible culture that values personal development and work-life balance. You will play a crucial role in enhancing audit methodologies and maintaining high standards of quality. If you are passionate about making a difference in patients' lives and thrive in a collaborative environment, this opportunity is perfect for you.

Benefits

25 days of vacation

Vacation days purchasing scheme

Discretionary Annual Bonus

Sabbatical of 3 to 6 months

Free food and beverages

Life Insurance

Health Insurance

Employee Assistance Programme

Flexible and hybrid work

Qualifications

• Bachelor's degree in a relevant field or substantial relevant experience.
• Recognised audit certification or extensive experience in GxP Audits.

Responsibilities

• Oversee GMDP vendor qualification and internal GXP audit programs.
• Manage regulatory inspections and client audits efficiently.
• Monitor audit program efficiency and guide improvements.

Skills

GxP Auditing

Quality Assurance

Risk Management

Regulatory Compliance

Continuous Improvement

Education

Bachelor's degree in Life Sciences

Audit Certification

Job description

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 Qualification and Audit Programs Manager to be responsible for overseeing GMDP vendor and supplier qualification processes, managing internal GXP audit programs, and coordinating client and regulatory authority audits. This role ensures compliance with industry regulations, drives continuous improvement, and maintains high standards of quality assurance through robust audit methodologies, resource management, and peer review of audit outputs.

What will your job look like?

• Develop and manage the internal audit program using a risk-based approach, with an annual audit schedule and auditor assignment
• Oversee risk-based GxP vendor and supplier qualification, ensuring assessments match the level of risk
• Create and maintain external audit schedules for vendors and suppliers; track delivery and completion
• Design and implement quality questionnaires to support vendor and supplier qualification
• Manage regulatory inspections and client audits, including scheduling, coordination, and response handling
• Oversee internal and external audit resource allocation, training, and professional development
• Conduct peer reviews of audit reports and provide constructive feedback to enhance auditor performance
• Maintain escalation processes for major/critical audit findings and ensure timely issue resolution
• Monitor audit program efficiency, regulatory changes, and trends in audit findings to guide improvements
• Contribute to Quality Management Review by reporting KPIs and metrics related to audit and qualification activities

What will you need to succeed?

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Quality Management), or substantial relevant experience in an Auditing role or QA environment
• Recognised audit certification or extensive experience in conducting GxP Audits
• Extensive knowledge of GDP regulations and legislation
• Working knowledge of GMP and GVP and applicable regulations and legislation
• Awareness of GCP regulations and requirements

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 [e-mail].

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