Senior Director, Quality & Compliance

Jobgether; Deutschland; Vor Ort; EUR 140.000 - 200.000; Vollzeit

Benefits dieser Stelle

Executive leadership exposure

Global cross-functional collaboration

Quality transformation initiatives

Patient-focused impact

Zusammenfassung

Jobgether on behalf of a partner company seeks a Senior Director, Quality & Compliance based in Germany. This senior leadership role shapes and executes a global quality and compliance strategy across clinical research services, providing strategic direction on quality management, regulatory compliance, inspection readiness, and enterprise risk.

You will lead quality transformation initiatives, work with senior executives, sponsor audits, and guide cross-functional teams to strengthen

Qualifikationen

• Bachelor's degree in Life Sciences or related field required.
• Advanced degree preferred (MSc/PhD/MBA).
• 10–15 years in QA, regulatory, or CRO roles.
• 7+ years leading global teams.
• Experience in CRO/pharma/clinical research essential, including outside QA.
• Deep knowledge of ICH-GCP, FDA/EMA/MHRA, 21 CFR Part 11, and GxP.
• Strategic, enterprise mindset with strong client focus.
• Excellent communication and executive presence.

Aufgaben

• Develop and execute global quality and compliance strategy.
• Lead quality management across clinical research services.
• Drive quality transformation and maturity initiatives.
• Provide guidance during regulatory inspections and sponsor audits.
• Lead global teams and engage with clients, sponsors, partners.
• Oversee QMS processes and governance.
• Present metrics and risks to executive stakeholders.

Kenntnisse

Leadership

Strategic thinking

Quality governance

Regulatory compliance

Inspection readiness

Executive communication

Ausbildung

Bachelor's degree in Life Sciences / related field

Advanced degree (MSc/PhD/MBA)

Jobbeschreibung

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Quality & Compliance based in Germany.

This senior leadership role is responsible for shaping and executing a global quality and compliance strategy across clinical research services.
You will provide strategic direction on quality management, regulatory compliance, inspection readiness, and enterprise risk.
The position combines executive leadership with client-facing responsibilities, supporting sponsors, strategic partners, and internal operational teams.
You will lead quality transformation initiatives designed to strengthen operational effectiveness, quality maturity, and client confidence.
The role requires close collaboration with senior executives and cross-functional leaders across a global clinical research environment.
You will also provide expert guidance during regulatory inspections, sponsor audits, client assessments, and significant quality events.
This is an opportunity to influence quality standards at enterprise level while leading high-performing global teams and advancing patient-focused clinical research.

Accountabilities

• Partner with the EVP, Global Quality to develop and execute the global quality and compliance strategy in alignment with corporate objectives and regulatory expectations.
• Provide leadership for quality management activities across clinical research services and ensure consistent alignment with applicable regulations and quality standards.
• Serve as a senior member of the Quality Leadership Team and contribute to enterprise-wide quality governance initiatives.
• Lead quality transformation and maturity initiatives that improve operational effectiveness, inspection readiness, and client confidence.
• Act as a senior quality representative for clients, sponsors, and strategic partners while building trusted relationships and providing strategic quality guidance.
• Lead and develop a team of Quality leads who provide customer-facing support, operational partnership, leadership, and functional expertise.
• Support business development activities, proposals, bid defenses, due diligence processes, and client governance meetings through quality and compliance expertise.
• Present quality metrics, compliance trends, risks, and improvement strategies to clients and executive stakeholders.
• Provide strategic oversight of Quality Management System processes and governance, including the global framework for quality issue management and CAPA effectiveness.
• Chair or oversee quality review forums addressing significant quality events, root cause investigations, remediation activities, and corrective actions.
• Provide executive oversight and strategic support for regulatory inspections, sponsor audits, and client assessments, including preparation, response strategies, observation management, CAPA development, and regulatory commitments.
• Monitor emerging regulatory requirements and industry expectations affecting clinical research organizations and advise leadership on their potential impact.
• Provide data-driven insights and recommendations through executive quality reviews and governance committees.
• Assess quality and compliance risks across operational functions and support effective mitigation strategies.
• Advise senior leadership on quality, compliance, inspection readiness, regulatory risk, and broader enterprise quality initiatives.

Requirements:

• A bachelor's degree in Life Sciences, Nursing, Pharmacy, Quality, Regulatory Affairs, or a related scientific discipline is required.
• An advanced degree such as an MSc, PharmD, PhD, or MBA is preferred.
• A minimum of 10–15 years of progressive experience in Quality Assurance, Quality Management, Regulatory Compliance, Clinical Research, or a related field is required.
• At least seven years of leadership experience managing global teams is required.
• Significant experience within a CRO, pharmaceutical, biotechnology, or clinical research environment is essential, including experience gained outside a dedicated QA organization.
• Advanced knowledge of ICH-GCP, FDA regulations, EMA guidance, MHRA requirements, PMDA expectations, applicable GxP regulations, vendor governance, risk management principles, computerized systems, 21 CFR Part 11, Quality Management Systems, and inspection readiness frameworks is required.
• Strong understanding of the clinical development lifecycle and CRO operations is essential.
• Familiarity with the application of AI within clinical research is expected.
• A strategic and enterprise-level mindset is required, along with strong customer focus and relationship management capabilities.
• Exceptional communication skills and executive presence are essential, with the ability to influence stakeholders across all levels of an organization.
• High integrity, accountability, sound judgment, and a strong commitment to quality excellence are essential for success.

Benefits:

• The role offers the opportunity to influence global quality and compliance strategy within a clinical research environment.
• The position provides senior-level exposure to executive leadership, clients, sponsors, strategic partners, and enterprise governance.
• The role offers the opportunity to lead global teams and drive meaningful quality transformation initiatives.
• The position supports a collaborative and inclusive working environment that values diverse perspectives, creativity, and professional growth.
• The work provides the opportunity to contribute to clinical research programs aimed at improving outcomes for patients and their caregivers.