As a member of the Global Quality (GQ) leadership team at Apellis, the Manager provides strategic direction, leadership, and management in the Global Quality function at Apellis.
Primary responsibilities for this role are to ensure successful investigation of product quality complaints received for commercially distributed and investigational products. Responsibilities comprise facilitation of the review of complaint data and investigation reports. Coordination of workload to ensure timely completion of investigations. Plan and manage projects. Ensure inspection readiness for complaint investigation related items. Ensure process is compliant with regulatory requirements and business needs in terms of receiving, documenting, investigating, resolving and responding to complaints.
Manages the receiving and handling (documentation, coordination, investigation, resolution and closeout) of all Product Quality Complaints and patient-related field events in a manner that complies with global regulatory requirements
Manages Apellis' processes pertaining to contact with healthcare professionals submitting product complaints
Reviews completed complaint files to assure proper documentation, coordination, investigation, resolution and closeout and ensure compliance to regulatory requirements as well as business requirements
Creates complaint and related CAPA trend analysis reports and submit to management to ensure early detection of potential quality issues
Gathers data to assist with any potential recall and/or reporting actions
Participates in internal audits and external quality system audits conducted by regulatory agency representatives
Monitors complaints for product trends and notify management of events requiring immediate action
Follow-ups with applicable complaint sources (study coordinators, physicians, pharmacies, sales reps, and hospitals) to obtain applicable information pertaining to reported events
Support Global Quality continuous improvement activities
Education and Experience
Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance, quality management systems, IT systems, training and education. Strong knowledge of deviation, investigation and/or complaint management preferred. Bachelor's degree in a life science required.
At least 7 years of pharmaceutical experience with increasing levels of leadership responsibility
Proven leader with exceptional problem solving and communication skills, with the ability to influence across all levels and functions within the Apellis organization.
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.
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.
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.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Apellis Pharmaceuticals, Inc.