Clinical Quality Assurance Manager

Boston, MA
Full Time
Clinical
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 Clinical Quality Assurance Manager will oversee GCP activities across various areas of development, ensuring compliance, and quality execution of clinical trials. The individual will lead and/or support GCP audits, maintain inspection readiness, and manage key relationships internally and externally. This impactful position requires proactive GCP CQA support, independent audits, and effective communication to enhance clinical development practices.  This role will report into the Head, GCP/GLP Quality Assurance.

Responsibilities and Duties
  • Actively collaborate with cross-functional teams in meetings and provide guidance to GCP functional groups based on interpretation of current regulations to ensure best practices including risk-based management
  • Provide proactive GCP QA support for clinical development to ensure patient safety, data integrity, compliance, and operational excellence
  • Develop and manage Audit Plans and Audit Reports
  • Oversee the audit response process and ensure acceptability of actions addressing findings during the various audits
  • Independently conduct audits, including Clinical Investigator Site Audits, GCP Document Audits, and support Internal Process Audits and Vendor/System audits
  • Draft, review, revise, or provide input to GCP/GLP SOPs to assess consistency and compliance with regulatory requirements and internal standards
  • Interact and manage contract auditors to help facilitate audit scheduling, conducting pre-audit meetings, drafting and reviewing audit plans, agendas, confirmation letters, peer review audit reports as appropriate
  • Work closely with GCP/GLP functional groups to ensure/coordinate appropriate and complete resolution of findings/non-compliances, deviations, investigations, CAPAs in a timely manner, including oversight and approval of all abovementioned activities, as necessary
  • Provide QA review of various procedures, clinical protocols, investigators brochure, clinical study reports, pharmacovigilance system management files, and other relevant documents as needed
  • Escalate issues of critical and major non-compliances and/or lack of urgency in remediation as appropriate
  • Drive continuous quality improvement by communicating audit results, CAPAs, and providing GCP guidance to clinical teams
  • Support health authority inspection preparation activities and provide oversight during inspections
  • Work collaboratively across the company to improve company QA processes and tools.
  • Keep current with industry developments – forthcoming regulations, guidance, best practices, etc.
  • Review and contribute to various clinical documentation
  • Compile and analyze audit metrics to identify trends
  • Conduct GCP training sessions
  • Work directly with third party vendors and contractors, managing effective chain of communication related to GCP/GLP/GVP compliance
Qualifications and Skills
  • Bachelor's degree in a related field, advanced degree a plus
  • Minimum of 4 years combined clinical experience with at least 2 years of direct GCP pharmaceutical/biotechnology experience in Clinical Quality Assurance
  • 2+ years of direct GCP pharmaceutical/biotechnology experience in Clinical Quality Assurance auditing
  • Experience with using risk-based principles and decision making to ensure ongoing compliance at all stages of product development
  • Experience working with all phases of clinical development, especially Phase III
  • Solid understanding and application of GCP/GLP guidelines and regulations
  • Fundamental knowledge of US, EU, and international regulatory standards and guidelines for clinical trials
  • Experience in supporting Regulatory Authority GCP Inspections
  • Experience in inspection management with strong analytical and report writing skills
  • Broad experience in GCP/GLP environments, regulatory compliance, and solid experience in GCP/GLP field auditing
  • Ability to represent the CQA Department with professionalism and exceptional interpersonal skills; solid knowledge of negotiation and conflict management skills to assure effective interactions with internal and external stakeholders
  • Technical and administrative capabilities to independently conduct routine, complex, and for-cause audits
  • Ability to assess complex issues, propose viable solutions, and follow through to resolution
  • A well organized, self-motivated, and independent work style with the ability to initiate and follow through on assignments
  • Professional communication skills, strong independent time management, and the ability to manage multiple projects concurrently while dealing with time demands, incomplete information, or unexpected events
  • Strong collaboration skills to engage with colleagues and partner within Regulatory Affairs, Clinical Operations and other groups as needed
  • Willingness to travel (approximately 25%)

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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