Director, GMP Quality Assurance

JOB SUMMARY

The Director of GMP Quality Assurance will be responsible for managing quality and compliance related to GMP operations for clinical and subsequent commercial drug substance and drug product manufactured and tested at Contract Manufacturing Organizations (CMO). Accountable for managing and driving batch record review, product investigations, deviations, complaints, escalation, change control, activities associated with Material Review Boards (MRB) and regulatory actions related to GMP activities, when required. Assist with the maintenance of the various quality system procedures and policies to ensure compliance with the current regulations and all applicable regulatory requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Oversee batch record review and batch disposition for drug substance and drug product and manage the release and disposition of all drug substances and clinical trial materials and reference standards.
• Evaluate, review and approve change controls, GMP investigations and deviations.
• Author deviations, change controls, risk assessments, product complaint investigations related to QA operations/systems.
• Development and maintenance of Quality Agreements with CROs.
• Review and approve master batch records, risk assessments, technical and validation protocols and reports.
• Conduct and support CRO audits as needed, gathering quality metrics, supporting and/or participating in quality management review, and escalations as required.
• Revise and/or author/implement procedures to support QA GMP operations.
• Assist in preparation of Health Authority Inspections, including follow-up efforts, to ensure successful outcomes.
• Partner with external and internal partners to ensure Corrective and Preventative Action Plans (CAPA) to address findings from incident investigations, audits or Health Authority Inspections are appropriate and effective.
• Maintain current knowledge and full understanding of compliance and regulatory requirements (FDA, EMA, MHRA, etc.) related to the manufacture of active pharmaceutical ingredients and drug products.
• Promote collaboration internally and with external partners to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines.
• Serve as QA representative on departmental and project team(s) representing CMC GMP.
• Establish metrics to evaluate the effectiveness of Quality Systems for GMP related activities. Develop processes for identification and management of the most important compliance risks for the GMP function and communicate risks to senior management.
• Facilitate the authoring, implementation, and maintenance of appropriate QA SOPs and Quality Manual for GMP related activities.
• Provide oversight and contribute to Gossamer’s document control program.
• Oversee the administration and management of Gossamer’s EDMS, EQMS and LMS.
• Manage a robust program for vendor qualification and compliance audits of contract manufacturers, packagers and testing laboratories, including preparation of Quality Agreements.
• Support validation activities related to facility, equipment, processes, and computerized systems at contract facilities.
• Work across departments and with contract manufacturers to ensure readiness for regulatory inspections and participate in inspections as needed.
• Provide input into the operating budget for the GMP QA function.
• Maintain currency with quality regulations and guidelines; understand and interpret regulations and guidance related to cGMP.
• Communicate and promote a culture of quality and operational excellence.
• Effectively represent Quality to regulatory agencies.
• Build, develop, and manage a high-performing Quality Assurance GMP team.

JOB QUALIFICATIONS

• Bachelor's degree in relevant scientific discipline is required. An advanced degree is preferred
• 12+years of hands-on experience with increasing responsibility in QA functions
• At least 7+ years in a managerial/leadership capacity
• Significant hands-on experience with small molecule drug development in a biopharmaceutical company.
• Experience implementing quality systems in a GMP environment, and direct experience with FDA and other health authority inspections.
• Experience establishing validated documentation systems and a strong understanding of 21CFRPart 11 requirements.
• Extensive knowledge of US cGMP and GLP compliance regulations and industry practices, as well as EU GMP requirements.
• Ability to critically evaluate and troubleshoot complex problems and attention to detail.
• Strong leadership and management skills.
• Excellent interpersonal skills with the ability to effectively interact with and influence different functional groups at all levels of management.
• Excellent verbal and written communication skills.
• Ability to manage multiple priorities and aggressive timelines.
• Office environment / Domestic and International travel up to 25% may be necessary.

Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.

The expected salary range for this position is $190,000 to $210,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law.  This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:

Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit https://www.gossamerbio.com/work-at-gossamerbio/