Director or Sr Director, Quality Assurance - GCP

Quality Assurance Waltham, Massachusetts


Description

Position Summary:

The Director of Quality Assurance in Clinical - GCP will be leading quality activities and responsible for managing all the efforts of establishing and leading QA function in clinical trials globally. He/She will oversee the global GCP and clinical audit quality function and represent Apellis as the key QA liaison with external vendors and CROs. The incumbent will also be responsible for establishing, developing and driving the company’s clinical quality systems and compliance strategies involving clinical trials and global marketing preparations.  Also, the Director will be expected to work with key business partners in contract clinical site management enterprises clinical research groups and nonclinical safety testing to assure compliance with GCPs and GLPs while meeting regulatory authorities and company’s goals in an effective and efficient manner. The incumbent is responsible for evaluating the compliance and guidelines of clinical studies to FDA and International regulatory agencies during IND, CTA, NDA, MAA, NDS, JNDA, etc.

The Director will also be responsible for identifying, recommending to clinical, medical affairs, biostatistics and data management groups in writing of clinical SOPs and training team members.  He/She will provide effective oversight of QA systems within clinical related groups and across functional team members involved in all clinical research activities.  The candidate must have the ability to develop and implement GCP-related quality systems and training of Apellis staff and able to oversee audit plans and activities so as to conduct effective audits of investigator sites, documents, Trial Master Files, vendors, and internal and external processes.

The Director will be responsible for planning, coordinating, controlling, and continuously improving the internal GCP-QA processes and systems.  He/She will assure quality awareness in conducting clinical studies and convey confidence in clinical knowledge providing a high understanding of clinical processes.  The Director will be expected to routinely interact with CROs, vendors and testing Labs to promote collaboration with these external partners to ensure all systems, processes, and their outcomes are in compliance with applicable national standards, international regulations and guidelines.  He/She should have the ability to actively leverage audit outcomes and trends to achieve sustained improvement in conducting clinical trials and reporting while championing the highest standards of compliance. Overall, it is Apellis expectation that the Director will establish and lead Clinical QA function while promoting a culture of quality-first across the company.

Responsibilities:

  • Provide guidance to personnel performing investigations, root cause analysis, CAPAs and deviations associated with QA-GCP compliance through knowledge of quality concepts and techniques
  • Point person to identify and communicate GCP quality and compliance risks and participate in determination of appropriate plan for resolving the issues and addressing risks
  • Develop and provide training on department-specific procedures and systems, write new QA documents, revise existing documents and identify Quality Process and system that need improvements and implement timely actions
  • Work with the clinical operations to develop and maintain audit programs for clinical sites with appropriate risk assessment and mitigation and also plan, track and oversee GCP internal audits and external Audits of contract laboratories and contract research organizations (CRO)
  • Create a Quality Assurance function to support GCP/GLP activities, writing new SOPs and revises existing Quality documents
  • Responsible for the Document Control function and management GCP-QA and implementation of electronic document management systems
  • Develop, mentor, train and maintain training records for staff on GCP requirements, provide support, guidance, required training to various department and GCP training to personnel. Also develop and keep current.
  • Plans, conducts and reports on GCP audits of clinical investigators, vendors, systems plus key reports and documents and facilitates regulatory inspections
  • Prepares and revises GCP SOPs, Work Instructions, creation and maintenance of audit tools and provides comprehensive internal GCP training programs, with a solid understanding of regulatory inspection processes
  • Participates in cross-functional teams providing guidance and risk based options and represents GCP QA on project teams to initiate, facilitate audit planning both internal and external audits
  • Works with cross-functional teams to provide GCP advice and supports the internal audit process with regards to documents and compliance and provides guidance on risk- based QA audit options
  • Reviews clinical study documents and checks for consistency and appropriate standards and practices
  • Reviews clinical study documents and checks for consistency and appropriate standards and practices
  • Coordinates projects to successfully meet timelines

Qualifications & Requirements:

  • BA/BS (or MS or Ph.D.) in any Life Science discipline is required with 12+ years’ in pharmaceutical and some medical devices
  • 5+ years of direct GCP Quality Assurance experience in regulated industry (pharma/biotech and medical device) with at least 10 years in biotech/pharmaceutical or related industry experience preferred
  • Broad knowledge of risk-based quality systems approaches consistent with ICH E-6 for Good Clinical Practice (GCP) 
  • Strong knowledge of Good Clinical Practices (FDA and ICH), a good understanding of 21CFR Part 11 with respect to clinical processes and systems, including database and eCRF validation procedures, eCTD Quality Assurance, and the ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner
  • Experience in leading inspection-readiness activities for FDA and other international regulatory agencies
  • Maintains good working relationships and communication with GCP customers and GxP QA audit staff
  • Knowledge of drug development, study design, data and trials management, procedures and documentation practices
  • Able to work in a fast paced environment while handling multiple demands and shifting priorities with flexibility and willingness to adapt in a changing environment
  • Excellent communication skills, both verbal and written, strong analytical skills and attention to detail
  • Attention to detail as well as a crisp, clear and concise style in written and oral communications
  • Demonstrated ability to flexibly work in a team and independently in a fast-paced, high growth environment
  • Other Requirements include:
    • Strong computer skills, project management skills, and a strong attention to detail, and the ability to manage multiple tasks
    • Experience managing internal personnel and external vendors
    • Extensive experience using electronic document management systems
    • Strong communication skills (both written and oral)
    • Ability to travel both domestic and internationally, as needed
    • Proficient in word processing, spreadsheets and database software applications on a PC, specifically MS Office: Word, Excel and PowerPoint

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.