The Role
Scendea is seeking a highly motivated individual to join our global team, in a permanent, full-time role, as Deputy Global Head of Quality, Senior Consultant, affiliated to the UK, with hybrid working from our Bishop’s Stortford office.
This is an excellent opportunity for an ambitious individual to progress their career at a rapidly growing product development, regulatory, and compliance consulting group, providing high-quality product development strategies, clinical trial compliance, and regulatory technical advice for our clients.
The ideal candidate will have a strong background in GCP auditing experience and the ambition to progress into a leadership role with the global team.
Role Requirements
- Lead the management, delivery and oversight of UK & EU Compliance Services and support with global compliance activities.
- Manage and conduct client contracted GCP audits including vendor qualification, project audits, system audits, live monitoring and inspection readiness. This may involve monthly travel across the UK and Europe, with occasional international travel as required.
- Lead issue resolution as a result of audit outcomes.
- Perform QMS gap analysis for Clients and develop high quality documentation such as Standard Operating Procedures and Policies in line with regulatory guidelines.
- Provide Clients with CRO Oversight services, acting as Sponsor’s representative for trials based in the UK and EU, providing real time oversight and support to CROs, trial sites and other vendors to align with Sponsor’s expectations and foster a cohesive team.
- Develop GCP Training as required by Clients.
- Support the Global Head of QA in the development and execution of quality initiatives.
- Support the maintenance of Scendea’s Quality Management System.
- Manage continuous improvement processes to ensure focus on service excellence.
- Serve as a point of escalation for the global project delivery team, consulting with Clients on issue resolution, creating and executing CAPAs and ensuring the quality register is updated.
- Achieve a billable target in a fast-paced consultancy through project management, contribution to the technical authorship, and review of compliance documents including; QMS gap analysis, client training modules, CAPA documentation, audit and issue resolution reports, according to area of expertise.
Skills and Experience
- A high scientific calibre with a relevant life science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life/physical science focused MSc or preferably a PhD).
- At least 5 years GCP auditing completion experience, including trial audits, CRO and vendor audits, system audits, qualification audits, regulatory inspection readiness audits and training.
- Experienced author of standard operating procedures.
- Excellent knowledge of ICH GCP with a foundational understanding of regulatory environments; GCP certification required.
- Proven ability to balance competing priorities and complete work within a set timeframe.
- A strong aptitude and experience in managing and mentoring others and a genuine interest in learning and development.
- Excellent organisational and time management skills with a high level of attention to detail, and strong interpersonal, communication, analytical, and problem-solving skills.
- Proven ability to work both proactively and autonomously.
- High level of verbal communication and presentation skills in English, computer literacy, and competency in MS Office programs and CRM systems.
- Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the country of employment, or internationally.
Benefits Package
- A competitive salary.
- Generous bonus program, which rewards success.
- 26 days’ holiday, public holidays, plus discretionary additional days for birthday and work anniversaries.
- Private healthcare.
- Pension contribution.
- Access to Employee Assistance Programme.
- Employee Ownership Trust Scheme.
- A challenging and stimulating position for a dynamic and competent individual, passionate about contributing to a growing business and a rapidly expanding team.
- Support of your professional development within a highly professional, internationally recognised, dynamic team.
- A unique working environment driven by strong company values and a very high level of employee engagement across the international organisation.
The Company
Scendea is an international product development, regulatory, and compliance consulting group delivering market-leading scientific expertise & regulatory solutions, to advance healthcare innovation worldwide. We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem-solving and redefining customer service. Our goal is to streamline the product development process, reduce time-to-market, and minimise overall development costs.
With a current team of over 50 staff based in the US, UK, Netherlands, and Australia, Scendea is undergoing a period of significant growth, with the addition of new service lines to facilitate the delivery of expert and strategic global regulatory and compliance consulting services to our rapidly growing client base. We are equally committed to making a positive impact on society by managing our environmental impacts and contributing to a low-carbon economy. Our inclusive work culture values transparency, ethical collaboration with clients, and employee involvement in key decision-making processes, ensuring that our team is respected, supported, and engaged.
As a Scendea Employee
Part of what makes Scendea successful is the highly motivated people who work for us and their enthusiasm for what we do and stand for. We recruit individuals whose passion, drive, integrity and customer orientation shines through. You are a motivated individual who can instil trust and confidence in our customer relationships whilst having a natural aptitude for getting the best out of people internally. You will inspire others through your commitment, motivation, expertise, professional manner and always placing the customer at the centre of everything you do.
Eligibility & Conditions
Applicants must reside and be eligible to work in the UK without the requirement for sponsorship now or in the future.
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