Manager, Quality Assurance

Non-small Cell Lung Cancer (NSCLC)

• HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
• HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
• HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

• HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role

The Manager of QA reports to the Director of QA and will provide quality oversight for the Product Complaint program. This will include investigation resolution for complaints associated with clinical and commercial material. The Manager will also be responsible for ensuring Summit departments and systems are inspection ready by way of conducting internal and external audits, supporting inspection readiness activities, and authoring and updating internal procedures and Quality Technical Agreements (QTA).

Role and Responsibilities

• Serve as the liaison for our commercial product complaint call center and also manage clinical product complaints.
• Ensure product complaints are investigated and resolved, in accordance with internal requirements and regulatory expectations.
• Support product compliant reconciliation with the call center and Pharmacovigilance.
• Continuously improve the internal product complaint program in accordance with applicable laws and regulations.
• Serve as Auditor for internal audits and external audits.
• Ensure internal and external audit responses and appropriate CAPAs are identified and managed through to resolution in a timely manner and deliverables are met.
• Continuously improve internal and external audit programs to remain current with applicable laws and regulations.
• Provide support for the initial review, periodic review, and revision of Summit QTAs.
• Write, revise, review and/or approve SOPs and other controlled documents.
• Ensure issues are identified and managed through resolution in a timely manner, management is notified, and deliverables are met.
• Participate in developing, reporting, reviewing and trending of quality and performance metrics, including in support of Annual Product Reviews (APRs).
• Support GMP inspection readiness activities.
• All other duties as assigned.

Experience, Education and Specialized Knowledge and Skills

• Bachelor's degree in chemistry, biochemistry, biotechnology, or other related life science discipline.
• Minimum of 5+ years of relevant experience.
• Experience managing product complaints.
• Strong knowledge of FDA, EMA, MHRA, ICH, PIC/S and international GMP/ GDP regulations governing clinical and commercial biologics.
• Experience serving as an auditor in both internal and external audits.
• Experience reviewing and approving QTAs.
• Demonstrated ability working within an eQMS to manage and close quality records in accordance with established timelines.
• Experience working with CMOs.
• Excellent communication skills both oral and written.
• Ability to work in a fast paced environment and efficiently manage projects and timelines.
• Experience working individually and within a team while balancing priorities.
• Attention to detail, accuracy, and thoroughness expected in all aspects of work.
• Self-motivated with a strong sense of work ethic.

This is the pay for this position

Pay Transparency $139,000—$163,000 USD

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

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