Über diese Senior Director, Quality & Compliance (Europe) Stelle bei Worldwide Clinical Trials
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What the Quality Assurance Department does at Worldwide
The Quality Assurance department sets the bar high when it comes to quality. We are committed to exceeding the quality standards required by our sponsors, study participants, and regulatory authorities. Our QA culture is based on an environment where staff are trained, energized, and empowered to deliver high-quality products to our employees and customers.
What you will do
Partner with the EVP, Global Quality to develop and execute the global quality and compliance strategy.
Provide leadership for quality management activities across all clinical research services, ensuring alignment with corporate objectives and regulatory expectations.
Serve as a senior member of the Quality Leadership Team and contribute to enterprise quality governance initiatives.
Lead quality transformation and quality maturity initiatives that enhance operational effectiveness, inspection readiness, and client confidence.
Act as a senior quality representative for clients, sponsors, and strategic partners.
Lead and grow a team of Quality leads, assigned therapeutically to provide customer facing support, leadership and internal operational team partnership, and support functionality.
Support business development, proposals, bid defences, due diligence activities, and client governance meetings by providing quality and compliance expertise & oversight.
Present quality metrics, compliance trends, and quality improvement strategies to clients and executive stakeholders.
Provide strategic oversight of Quality Management System (QMS) processes and governance.
Support the leadership of the global governance framework for quality issue management and CAPA effectiveness.
Chair or oversee quality review forums to assess significant quality events, root cause investigations, and remediation activities.
Provide executive oversight and strategic support for regulatory inspections, sponsor audits, and client assessments.
Support inspection preparation, response strategy, observation management, CAPA development, and regulatory commitments.
Maintain awareness of emerging regulatory requirements and industry expectations affecting clinical research organisations.
Support executive quality reviews and governance committees through data-driven insights and recommendations.
Assess quality and compliance risks across operational functions and support effective risk mitigation strategies.
Provide expert consultation to senior leadership on quality, compliance, inspection readiness, and regulatory risk.
Contribute to enterprise risk management activities and quality-related strategic initiatives.
What you will bring to the role
Advanced knowledge of: ICH-GCP, FDA regulations, EMA guidance, MHRA requirements, PMDA expectations, Vendor Governance applicable GxP regulations, Risk Management principles, Computerised Systems and 21 CFR Part 11, Quality Management Systems and inspection readiness frameworks.
Strong understanding of the clinical development lifecycle and CRO operations.
Understanding of AI as applies to clinical research applications.
Strategic and enterprise mindset.
Strong customer focus and relationship management skills.
Exceptional communication and executive presence.
Ability to influence at all organisational levels.
High integrity, accountability, and commitment to quality excellence.
Your experience
Bachelor's degree in Life Sciences, Nursing, Pharmacy, Quality, Regulatory Affairs, or related scientific discipline required.
Advanced degree (MSc, PharmD, PhD, MBA) preferred.
Minimum 10-15 years of progressive experience in Quality Assurance, Quality Management, Regulatory Compliance, or Clinical Research.
Minimum 7 years of leadership experience managing global teams.
Significant experience within CRO, pharmaceutical, biotechnology, or clinical research environments (can be outside of the QA organisation).
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.