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Head of Clinical Quality Assurance
hace 1 mes
Company Overview
Rhythm is a global biopharmaceutical company dedicated to transforming the lives of patients with rare neuroendocrine diseases. We develop innovative medicines and provide support for healthcare providers and patients.
Opportunity Overview
The Head, GCP Quality Assurance will lead clinical quality assurance operations, ensuring compliance with regulatory standards and driving continuous improvement of Good Clinical Practices (GCPs). This role will collaborate with cross-functional leaders to develop and implement global quality strategies, aligning with Rhythm's goals and objectives.
Responsibilities and Duties
- Lead the clinical quality function, ensuring compliance with applicable regulations, industry standards, and company policies.
- Drive a culture of continuous improvement by identifying areas for enhancement and implementing process improvements.
- Develop strategies to identify and mitigate related risks across clinical activities.
- Establish and maintain robust clinical quality standards, developing and implementing standard operating procedures (SOPs), quality manuals, and other related quality documents.
- Provide leadership and oversight for training programs related to clinical quality assurance.
- Establish and monitor quality metrics and key performance indicators for the effectiveness of clinical quality assurance activities.
Qualifications and Skills
- Bachelor's degree in a relevant field, such as nursing, pharmacy, or public health.
- 12+ years of industry experience in pharmaceuticals, devices, or research, with a focus on quality systems and regulatory compliance.
- 5+ years of leadership experience, with a proven track record of motivation, cultural awareness, and relationship building.
- Excellent communication and negotiation skills, with the ability to manage difficult conversations and prioritize multiple tasks simultaneously.
About Rhythm
We are a dynamic and growing global team dedicated to transforming the lives of patients with rare neuroendocrine diseases. Our core values include advancing scientific understanding, tackling tough challenges, and collaboration and ownership. Rhythm is an equal employment opportunity employer and does not discriminate against any applicant based on race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, or any other protected class.
