Assoc. Director, Clinical Quality Assurance

Our ideal candidate is a self-motivated individual who has a passion for clinical quality and can thrive in a fast-paced dynamic environment. The Associate Director GCP Quality is responsible for leading Clinical Quality Assurance (CQA) activities for clinical development programs, including the management of audits, quality issues and investigations, and inspections. This position requires a depth of understanding and significant experience in GCP and compliance, leadership, and communication skills to conduct responsibilities independently. This role is accountable for Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with our Company's Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g., United States FDA, European Union Directives, ICH, and National regulations).

This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote. Remote arrangements may be considered for highly qualified individuals.
 
Responsibilities (including, but not limited to):

• Provide professional expertise and guidance on GCP, GLP and Good Pharmacovigilance Practices (GPV) regulations and other applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations
• Provides clinical quality strategy
• Fosters a collaborative working relationship with key stakeholders (e.g., regional study team members, global clinical operations compliance team members, etc.)
• Liaise with various Kiniksa's functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for programs; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance
• Support GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and study documents to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines.
• Support Oversight of the Commercial Pharmacovigilance Program
• Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP/GLP/GPV and Kiniksas policies and procedures.
• Lead investigations into significant quality issues, scientific misconduct and serious breach of GCP/GLP/GPV, if they occur; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities
• Lead and support GCP/GLP/GPV health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Kiniksas
• Provide Clinical QA oversight of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents as requested.
• Analyze, report, and present metrics for assigned programs to development teams, R&D, and Quality management; recommend any required actions and monitor implementation
• Collaborate with Quality team to identify and mitigate GCP/GLP/GPV quality and compliance issues with potential impact across multiple programs or functional groups
• Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
• Stays abreast of new and revised government, industry and company regulations, trends and interpretations by participating in trainings, conferences, workshops and discussion groups as appropriate
• Other duties as assigned

Qualifications and Experience:

• B.S degree in life sciences with 10+ years of progressive global quality/regulatory compliance background in pharma/biotech or medical device industries, with a hands-on role in clinical quality operations and quality system preferred
• Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered.
• Auditor certifications a plus.
• Requires solid experience supporting Phases I-IV (particularly Phase III); experience with Regulatory submissions and/or approval.
• Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required.
• Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs is essential.
• Broad knowledge of risk-based quality systems approaches consistent with ICH E6 and ICH E8 
• Previous hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS required
• A strong customer focus and ability to prioritize and adapt to business needs are required
• Strong business partner with a focus on collaborating and delivering results
• Self-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities
• Understanding and knowledge of applicable industry regulations
• Ability to interact constructively and efficiently within and across functional areas and management
• Ability to resolve day-to-day issues efficiently while maintaining compliance
• Provide imaginative, thorough, and practical solutions to problems
• Solve conflict and address workplace issues in professional and collaborative manner