Director, Quality Assurance Audits

Quality Assurance Waltham, Massachusetts


Description

Position Summary:

The Director, Quality Assurance Audits is a key member of our Quality team and is accountable for the leadership of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations. This includes conducting a variety of audit activities which may include, but not be limited to, vendor audits, internal process audits, pharmacovigilance system audits, study specific audits (e.g. investigator site, in process, pharmacy/distribution, trial master file), managing sponsor audits, inspection support, and country office audits. In this role, the successful candidate must be able to set up strategic direction for QA audits by providing leadership of all GxP audit functions covering GLPs, GMPs and GCPs and also ensure the development, execution of a risk based audit program to fulfill global regulatory requirements primarily in North America, Europe, Latin America and Asia Pacific regions.

This individual will be responsible for quality activities related to oversight and management of clinical trial execution, including development and execution of study level audit plans, monitoring/trending of quality and compliance metrics, deviation/CAPA management and inspection readiness. Experience with key performance indicators, metrics analysis, and monitoring/trending of quality and compliance metrics is advantageous. The ideal candidate is someone who is not afraid to dive in and help develop this expanding team. The successful candidate will drive, promote and embed a culture of ethics, integrity and continuous improvement that will focus on delivering efficiencies and planned business benefits to support Apellis moving through the development to marketed products. 

Key Responsibilities Include:

  • Leads, directs and/or performs internal audit, implements inspection preparedness to assure GxP compliance of internal operations including mock inspections. Establishes quality metrics for audits and inspections and execute against these metrics consistently in preparation for pre-approval inspection by global regulatory authorities.
  • Lead quality system audits of external GCP/GLP vendors, clinical investigator sites internal GCP/GLP processes and documents. This position will establish, implement and maintain GCP and GLP compliance systems in support of all phases of the company clinical and non-clinical trials.
  • Ensure compliance to all relevant US and international regulations / laws as relevant to regulatory compliance and leadership on QA management and that the integrity and quality of our product and the supply chain is legally registered in the applicable countries prior to distribution.
  • Provide strategy, leadership and execution and/or oversight of quality monitoring and assurance of clinical trial execution for assigned programs.
  • Execution and/or oversight of Clinical Investigator audits, Documentation Audits and other study-specific or process audits.
  • Engage with study teams and functions for proactive inspection readiness across assigned programs/areas.
  • Analyze, report and communicate metrics along with proposals for process improvements.
  • Responsible for triaging, reviewing and approving Quality Issues and CAPA.
  • Provide regulatory compliance support & guidance to cross functional clinical study teams.
  • May serve as GCP Quality Management System representative
    • Participates in collaborative review of impacted SOP/WI
    • Reviews and analyzes key Performance Indicator data and trends
    • Analyzes risk and proposes remedial, corrective and /or preventive actions
    • May participate on process improvement initiatives
  • Provide support for Health Authority Inspections (preparation, support and follow-up activities).
  • Develop, maintain and ensure execution of strategic protocol specific audit plans and audit closure/summary reports for assigned people/programs.
  • Monitors and trends events related to their process and identifies/proposes corrective actions.
  • Identifies risks/communicates gaps to Quality System Owner.
  • Identifies and generates process related metrics- monitors for efficiency.
  • Lead/coordinate internal quality improvement initiatives as appropriate.
  • Other duties as assigned.


Education, Registration & Certification:

  • Doctorate, Master's, or Bachelor's degree in a life science field (Biology, Chemistry, or Pharmaceutical sciences in a scientific or allied health field) with required years of experience. A minimum of 10 years QA experience within biotech and pharmaceutical firms. Participated in global marketing submission, review cycles and post-approval management activities.

Experience:

  • A hands-on leader with previous managerial experience who leads by example, inspires and empowers team members.
  • 5+ years of experience in early or late phase clinical research OR a GxP regulated environment and 4+ years’ experience quality management or quality assurance experience in GxP environment.
  • Strong knowledge of GxPs (GLP, GMP, GCP); Must have demonstrated experience with GCP auditing.
  • Demonstrated functional leadership experience is required. Vendor audit experience in a variety of vendor types is a must.
  • Inspections and investigation experience are required.
  • In-depth knowledge of:
    • Auditing-language/roles/skillset - Interviewing, Deduction and Investigation skills with subject matter expertise on Clinical Investigator site and GCP document audits with ability to train others.
    • Clinical Documentation (e.g. Investigator’s Brochures, Clinical Study Reports, eCTD Module 2 documents for regulatory submissions, etc.)
    • ICHE6 (R2), 21 CFR Part 50, 54, 56, 312, 314, and familiarity with 21 CFR Part 11 and international equivalents, best practices, and industry standards.
    • Event Management process and requirements, including investigation, root cause analysis, CAPA plan development and effectiveness checks.
    • Change Management principles and process.
  • Communication, Influencing, Presentation and Facilitation skills at all organizational levels.
  • Pro-active in identifying opportunities with a strong solution minded approach and flexibility to emerging challenges.
  • Strong collaborative, influencing and interpersonal skills with excellent verbal, written and presentation skills with the ability to deal effectively across all levels of management.
  • Ability to prioritize competing activities and manage resources and budget accordingly.
  • Ability to maintain and create professional networks with stakeholders internally and externally.
  • Other duties as required. 

Preferred Qualifications:

  • Proven experience with all phases of clinical trial execution Phase I – IV trials.
  • Previous experience with validation and change control preferred.
  • Previous participation on material review and product complaint boards (or equivalent) preferred.
  • Quality Management Systems within GCP discipline.
  • Proven experience with quality assurance oversight and metrics management/monitoring in support of proactive quality risk management.
  • Ability to provide GCP compliance interpretation, consultation, training and support to study execution team.
  • Ability to understand and translate customer needs for innovative and creative approaches to quality management.

Skills, Knowledge & Abilities:

  • Comfortable working independently.
  • Strong financial management capabilities.
  • Highly organized, results driven, problem solver.
  • Superior written and oral communication skills and the ability to work with different levels of management.
  • Highly motivated with the ability to be flexible in a fast-paced environment .

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more.

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.