Senior Manager, Clinical Quality Assurance
Reports to: Senior Director, Quality Assurance
Location: This position may be primarily performed remotely with approximately 20% travel, US and International.
Position Summary
The Senior Manager, Clinical Quality Assurance, reporting to the Senior Director, Quality Assurance, is a central member of the QA team responsible for ensuring the quality and clinical compliance of operations with corporate policies, industry standards, and applicable regulations. This role will be responsible for working closely with the clinical study teams to provide clinical compliance support and ensure inspection readiness.
Primary Responsibilities
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Attend cross-functional study team meetings and provide compliance guidance to staff based on interpretation of current regulations to ensure best practices.
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Support Clinical Operations to design and implement a Risk-Based Quality Management framework for clinical studies, Risk Assessment Tools, and Risk-Based Monitoring processes.
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Support study teams in reporting and performing root cause analysis of Deviations and Compliance Issues and creating effective CAPA plans as needed.
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Participate in review of emerging regulations and guidelines across the organization to ensure regulatory compliance.
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Maintain and improve quality assurance and compliance strategies in collaboration with
the QA team. -
Participate in the development of departmental standard operating procedures, work instructions, forms, and templates.
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Support Inspection Readiness activities and participate in Health Authority Inspections
Qualifications and Key Success Factors
Education and Experience:
- Bachelor's degree in the Life Sciences and 7+ years of in pharmaceutical or biotech drug development. Minimum 5 years of experience in a GCP compliance/ quality role.
- Strong knowledge of Regulatory guidelines (ICH, FDA, EMA, MHRA).
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Experience working on global clinical research studies conducted in US and EU.
- Auditing experience and GCP Certification a plus (e.g., CQA, SQA).
Technical Skills and Expertise:
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Exceptional understanding of ICH GCP requirements with knowledge of global and regional regulatory requirements applying to Clinical Trials. (FDA Regulations, EU Directives, ICH guidelines).
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Experience overseeing CROs and other Third-Party Vendors.
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Experience with CSV procedures, EDC, and ePRO systems.
- Thorough understanding of clinical research, drug development, and operational activities and processes.
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Experience working within a Quality Management Framework including elements such as Procedural Document Management, Risk Management, Third-Party Management, and CAPA management.
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Ability to influence others as part of a collaborative team and negotiate effective solutions, strong interpersonal and social skills.
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Ability to work in an Agile work methodology, think independently, and adapt quickly.
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Excellent active listening, communication, and collaboration skills to work effectively on cross-functional global teams.
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Must be able to organize and prioritize work effectively to meet timelines with quality deliverables.
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Strong attention to detail and respect for the need of accuracy of information.
Compensation & Benefits
At Praxis, we’re proud to offer an exceptional benefits package that includes:
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99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
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Bonus program structured to pay on a quarterly basis
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401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
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Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
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Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
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Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)
To round out this world-class total rewards package, we provide base salary compensation in the range of $155,000 to $170,000 annualized. Final salary range may be modified commensurate with job level, education, and experience.
Company Overview
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE™ to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
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