Puma Biotechnology Inc.
does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters.
This position will work with the Sr.
Director, R&D Quality Assurance, and will be responsible for administration and maintenance of the quality management systems at Puma Biotechnology.
This position will be responsible for the Product Quality Complaints and vendor management programs.
This position will also support the audit program and other Quality Systems at Puma, as required.
The Manager, R&D Quality Assurance, will possess a functional familiarity with US and International regulations and guidelines as they pertain to Good Manufacturing, Clinical, Laboratory, and Pharmacovigilance Practices (GxPs).
Major Duties/Responsibilities
o Maintain a working knowledge of current FDA and ex-US (e.g.
EU and ICH) regulations and guidances governing GCP, GLP, and GPvP
o Assist QA management in ensuring the quality and compliance of Puma’s Research and Development activities with respect to internal procedures and global regulations (e.g.
FDA, ICH, EU and other country-specific requirement)
o Communicate significant deviations or other compliance issues to QA management
o Review and follow internal SOPs
o Support the preparation, coordination, and management of regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspections, and provide expertise and assistance to other departments, as required
o Support the organization in maintaining a work environment focused on quality and that fosters respect, open communication, collaboration, and teamwork
o Product Quality Complaint Management
* Monitor the QA product complaint mailbox daily and log complaints received from the call center, and applicable commercial partners
* Review complaints to ensure required information is captured by the call center and commercial partners
* Communicate with the call center and commercial partners for any follow-up queries of the complaint case
* Coordinate sample return from the complainants, request retention samples from vendors, and send samples to testing laboratory where necessary
* Coordinate with Puma stakeholders and CROs for the proper handling and investigations of complaints related to IP and comparator’s product used for Puma clinical trials
* Review and approve complaint investigations and the associated CAPAs from contracted vendors (e.g.
CMOs, packaging/labeling vendors, third-party logistics, and distributors) to ensure the complaint is fully addressed
* Assist in conducting complaint investigations where necessary
* Escalate issues to management related to nonconforming product, complaint trends, etc.
* Draft and send complaint acknowledgement and closure letters to the complainants
* Performs reconciliation on a weekly basis, including monitoring the complaint status, timeliness of closure, and verification of CAPA completion
* Support quality metrics development and annual product review (APR)
o Vendor Management:
* Work with Puma staff to ensure vendors are qualified to perform contracted services
* Work with vendors on completion of qualification criteria, including questionnaires, facility audits, reference checks, etc.
* Coordinate with vendors and the Head of QA to finalize Quality Agreements
* Ensure vendors are reviewed periodically to maintain the quality of the contracted services
* Track vendor qualification activities, and report status to management quarterly
* Coordinate the vendor audit program
o Audit Management
* Coordinate the internal audit program
* Coordinate the vendor audit program
* Coordinate the TMF audit program
* Coordinate the clinical site audit program
* Conduct audits as required
* Follow-up on audit deliverables to completion
Skills and Abilities
* At least 5 years of proven experience in clinical compliance or clinical quality assurance, including the conduct/coordination, reporting, and closing of audits (vendor, document, database, and investigator site)
* Effective written and verbal communication skills, with the ability to communicate clearly and concisely
* Good understanding of the clinical development process
* Strong interpersonal skills, team player, and flexible without compromising quality
* Comprehensive knowledge of global regulations related to the clinical development process, including GCP, GLP and GPvP regulatory requirements, and their practical implementation
* Ability to take ownership of specific projects, and to effectively work with cross-functional team members on projects
* Skilled in methods of discovery, root cause analysis, improvement/correction planning and implementation
* Ability to travel domestically and internationally for conducting audits of clinical vendors and clinical investigator sites
* Ability to establish collaborative working relationships with internal and external stakeholders
* Self-motivated and able to effectively prioritize and manage multiple projects and tasks in a fast-paced environment, with the ability to meet fast-track timelines
* Excellent time and project management skills
Required Education and Professional Experience
* B.S.
degree in a scientific discipline
* 5-6 years of demonstrated experience working within the quality environment in the pharmaceutical or biotechnology industry, with specific experience in GCP/GLP/GPvP quality assurance auditing and their respective regulations
* Comprehensive working knowledge of local, state, federal, and international regulations pertaining to GCP, ICH guidelines, and HIPAA requirements
* Complete and thorough understanding of global GCP regulatory requirements (e.g.
US FDA, European Union etc.)
* Auditor training or certification a plus
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job.
Duties, responsibilities and activities may change at any time with or without notice.
Physical Demands
The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.
The physical demands of the office are normally association with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain.
While performing the duties of this job, the employee is frequently required to stand, walk, sit, use hands, reach with hands and arms, climb stairs, balance, stop, kneel, crouch or crawl, talk, or hear.
The employee must occasionally lift or move up to 25 pounds.
Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
Travel
This position may require overnight travel, both domestic and international, typically 20% or more as business needs dictate.
Equal Opportunity Employer
Puma Biotechnology, Inc.
is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by law.
(function () {‘use strict’;socialShare.init();})();