A clinical-stage biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Reporting directly to the Executive Director QA & Compliance, you will contribute to ensure compliance with applicable quality objectives and regulatory requirements for parenteral drug products. In this role, you will have an important focus on ensuring GXP compliance with an emphasis on GCP compliance. You will help drive and implement the Company’s compliance directives and supporting quality management systems to ensure compliance. This position will conduct and/or be the Lead in GCP QA audit programs which includes both internal and external GXP audits, and will provide day to day support to the Executive Director Quality Assurance and Compliance to manage CMOs, CROs, investigator sites, relevant vendors, etc.
Specific responsibilities include, but are not limited to:
• Writing and/or implementing changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met.
• Maintaining document control program.
• Implementing and maintaining programs and processes to ensure compliance with current Good Manufacturing Practices (GMPs), Good Clinical Practice (GCPs) Good Laboratory Practices (GLPs) and current industry practice.
• Working with and qualification of GCP vendors.
• Provide QA support and oversight to ensure compliance with Good Clinical Practice (GCP).
• To ensure all clinical trials are assessed for compliance with SOPs, FDA and other applicable regulations, and ICH/GCP guidelines.
• Participate in and support all GCP QA internal and external vendor management programs.
• Participate in ensuring compliance with external SOPs, e.g. CAPA, deviations, OOS, etc.
• Reviewing and approving manufacturing master batch records, executed batch records, in-process/finished product quality control data for timely disposition of drug product intended for human use.
• Interfacing with contract manufacturing organizations (CMOs) to address documentation and compliance issues including investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
• Preparing lot disposition reports, reviewing planned changes, deviations, analytical reports, laboratory investigations, change controls, method and process validation protocols and reports for management review.
• Working extensively with the Head of Quality to ensure that inspections and audits are conducted on a continuing basis, to enforce requirements and meet specifications. May assist or perform GxP compliance audits as required.
• Interacting with Manufacturing, Supply Chain and Regulatory Affairs personnel to ensure that commercial drug products are manufactured and tested in accordance with established procedures.
• Working with Research and Development during new product start-ups, and establishing key checkpoints for new products and processes.
• Adherence to the Code of Business Conduct & Ethics
• Other duties as assigned.
• Demonstrated in-depth knowledge of Quality Systems, ICH guidelines and cGMP standards applicable to commercial Drug Product (21CFR 210 and 211) and knowledge of European regulations.
• Working knowledge of GCP regulations and EU directives
• Ability to interface with other functions like manufacturing, distribution and clinical operations
• Demonstrated audit, investigation and report writing skills
• Working knowledge and expertise in manufacturing and/or testing of sterile products
• Ability to recognize deviations from accepted practice and apply knowledge of current Good Manufacturing Practices (cGMP) on a daily basis
• An accountable team player who is detail and quality-oriented with solid understanding of quality assurance principles, systems, methods and procedures
• Excellent verbal, written and interpersonal communication skills required
• Experience working within a virtual company environment
• Excellent attitude and strong multitasking skills
• Ability to adapt to changing priorities and timelines and work well in high pressure environments
• Possess critical thinking skills when making sound quality decisions based on risk management and available data
• 6+ years of experience in a GCP/GMP environment or related field and a BS or BA
• 4+ years of relevant experience and a MS