Senior Manager, Clinical QA

Location:  This position may be primarily performed remotely with travel to the Boston area as needed, plus 20% travel for role specific responsibilities (both Domestic and International)

The Opportunity
The Sr. Manager of Clinical QA, reporting to the Sr. Director of 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 will provide expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigation. They will work with internal clinical functions and external parties including consultants, contract auditors, CROs and investigator sites to promote a high level of quality and consistency across and within clinical research programs. 

Primary Responsibilities

• Provide expertise in GCP, compliance interpretation, consultation, training, and recommendations to clinical development functions and program teams.
• Support Clinical Operations to design and implement a risk-based quality management framework for clinical studies including risk assessment tools.
• Support study teams in reporting and performing root cause analysis of deviations and compliance Issues, and creating effective CAPA plans as needed.
• Participate in review of emerging regulations and guidelines across the organization to ensure regulatory compliance.
• Maintain and improve quality assurance and compliance strategies in collaboration with the QA team.
• Support inspection readiness activities and participate in health authority inspections.
• Participate in due diligence activities and process improvement initiatives as requested by management. 
  

Qualifications and Key Success Factors

• Include key qualifications and success factors
• Bachelor's degree in Life Sciences, with 7+ years of experience in pharmaceutical or biotechnology drug development, and minimum of 5 years of experience in a GCP compliance/quality role.
• Strong knowledge of regulatory guidelines (ICH, FDA, EMA, MHRA).
• Experience working on global clinical research studies conducted in US and EU.
• Auditing experience and GCP Certification desired (e.g. CQA, SQA)
• Exceptional understanding of ICH GCP requirements with knowledge of global and regional regulatory requirements applying to Clinical Trials. (FDA Regulations, EU Directives, ICH guidelines).
• Demonstrated experience in negotiating and managing performance of CROs and other external partners supporting study execution.
• Experience with CSV procedures, EDC, and ePRO systems. 
• Thorough understanding of clinical research, drug development, and operational activities and processes.
• Experience working within a Quality Management Framework including elements such as Procedural Document Management, Risk Management, Third-Party Management, and CAPA management.
• Ability to influence others as part of a collaborative team and negotiate effective solutions, strong interpersonal and social skills.
• Ability to work in an Agile work environment, think independently, and adapt quickly.
• Excellent active listening, communication, and collaboration skills to work effectively on cross-functional global teams.
• Must be able to organize and prioritize work effectively to meet timelines with quality deliverables.
• The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position. Work is performed in a remote, work from home environment. The employee is regularly required to sit; use hands and fingers; reach with hands and arms; and talk and hear. The employee is occasionally required to stand, walk, and climb or balance. Movement through sites and labs may occasionally be required as employee may need to visit these environments. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Visual acuity is required to read and produce accurate materials. Use of keyboards and cellular devices.

Compensation & Benefits

At Praxis, we’re proud to offer an exceptional benefits package that includes:

• 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
• Bonus program structured to pay on a quarterly basis
• 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
• Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
• Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
• Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)

To round out this world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.