Head, GCP/GLP Quality Assurance

Boston, MA
Full Time
Regulatory
Experienced
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Opportunity Overview
The Head, GCP Quality Assurance provides strategic leadership and direction for clinical quality assurance operations and other prioritized needs, ensuring Rhythm’s drug development programs comply with regulatory standards and driving continuous improvement of Good Clinical Practices (GCPs). The role collaborates with cross functional leaders and stakeholders to develop, implement, and leads global quality strategies that align with Rhythm’s goals and objectives, setting the overall vision and long-term priorities for the Clinical Quality Assurance organization.  This role reports into the SVP, Global Regulatory Affairs and GCP/GLP QA.

Responsibilities and Duties
  • Lead the clinical quality function ensuring compliance with applicable regulations, industry standards, and company polices across tactical and strategic initiatives.
  • Drive a culture of continuous improvement by identifying areas for enhancement, implementing process improvements, and promoting best practices to enhance an overall culture of quality, efficiency, and compliance.
  • Drive the strategic planning process for the Clinical Quality Assurance organization through ongoing assessment of regulatory, industry, technological, and internal trends/best practices, determining impact to the business.
  • Develop strategies to identify and mitigate related risks across clinical activities.
  • Establish and maintain robust clinical quality standards. Develop and implement standard operating procedures (SOPs), quality manuals, and other related quality documents.
  • Develop and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical programs. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.
  • Consult and partner with the clinical program team to provide compliance guidance across investigator sites, vendors, and internal processes. Lead regulatory inspections, ensuring preparedness and appropriate responses to findings and observations.
  • Provide leadership and oversight for training programs related to clinical quality assurance. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures.
  • Establish and monitor quality metrics and key performance indicators for the effectiveness of clinical quality assurance activities.  Prepare regular reports and presentations for executive management highlighting quality performance, trends, and areas for improvement.
  • Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of clinical quality assurance activities. Build and maintain effective relationships with internal and external stakeholders.
  • Lead, develop, and mentor the clinical quality assurance team, responsible for the execution and sustainability of GCP across the portfolio. Set clear expectations, manage performance, and foster a positive collaborative working environment for a diverse team.  Develop talent and build a skilled motivated team.

Qualifications and Skills
  • Bachelor's degree required, preferably in Nursing, Pharmacy, Public Health or other biological/medical science degree combined with equivalent technical experience.
  • 12+ years industry experience in any combination of pharmaceutical, device, combo/device, research, development, clinical research, quality systems, or a combination of those or comparable experiences. 
  • Thorough understanding of global and local clinical trial/study regulatory requirements and processes.
  • 5+ years’ leadership experience and exemplary tactics in motivation, cultural awareness, active engagement, relationship building, sound judgment, and the management of sensitive information and situations. 
  • 5+ years’ people management experience in motivating and developing high-performing teams (direct and indirect reports) with challenging goals that foster growth, learning and engagement.
  • Excellent communication skills, including superior negotiation and influencing skills. Acute listening skills to gain understanding or to solve a problem and the ability to recognize the difference. Ability to manage difficult conversations and seek alignment and target messages to key stakeholders effectively.
  • Ability to be hands on and direct and coach all aspects of work projects (strategic and tactical) effectively.
  • Comfortable prioritizing and balancing multiple tasks simultaneously within evolving and at times, rapidly changing priorities and deadlines.

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.


More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.  Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.

At Rhythm our core values are:
  • We are committed to advancing scientific understanding to improve patients’ lives
  • We are inspired to tackle tough challenges and have the courage to ask bold questions
  • We are eager to learn and adapt
  • We believe collaboration and ownership are foundational for our success
  • We value the unique contribution each individual brings to furthering our mission
Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.

Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.

 
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