Sr. Manager, Clinical Quality Assurance

About the company

The company Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At the company, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. The company’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

The company’s team is inspired to touch and help change lives through the company’s clinical studies in the field of oncology. The company has multiple global Phase 3 clinical studies, including:

Non-small Cell Lung Cancer (NSCLC)

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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.

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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.

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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)

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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). The company is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role

Collaborate closely with Regulatory Affairs, QA, R&D and other cross functional teams within the company to provide GCP/GLP/GPV and compliance-related advice to internal clinical study teams. This will be accomplished through ensuring tactical support is provided to assignments and wherever necessary, taking the lead in ensuring project related procedural documents, comply to relevant GxPs and regulatory requirements and guidelines.

Role and Responsibilities

• Partnering and collaborating with key stakeholders (R&D teams) to ensure that appropriate Quality support is provided to the company Clinical and pre-clinical programs.

• Managing Audits which include Clinical Sites and Vendor Qualification

• Ensuring end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP).

• Liaising with the Global Audits and Compliance function to provide lessons learned from audits and inspections to program teams and support implementation of corrective actions.

• Supporting CRO-relevant meetings, when necessary, to provide quality overview/ training to relevant stakeholders.

• Providing support during the development and execution of Corrective and Preventive Actions (CAPAs). Coordinating and reviewing CAPAs to ensure adequate CAPAs are defined, implemented, and closed.

• Support formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidents are not resolved in due course.

• Identifying areas of continuous process improvement and engaging QA and key stakeholders as necessary.

• QA support in interactions with internal and external contacts and Health Authorities (HA), as appropriate. In collaboration with the Global RD/PV QA team, ensure inspection management by assisting in preparing program teams for FDA, EU, and key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspections.

• Support in providing interpretation of regulations and company process standards, guidelines, policies, and procedures to personnel for assigned programs or for continuous improvement projects.

• Supporting or leading development and driving the implementation of study/program-specific quality plans to ensure proactive management of quality.

• Supporting rectifying any necessary vendor-relevant issues identified for the assigned program.

• Ensuring that protocols for assigned programs can be operationalized and address potential risks with key stakeholders.

• Perform internal audits in support of the Quality Systems internal audit program

Experience, Education and Specialized Knowledge and Skills

• Bachelor's Degree in Life Sciences, Pharmacy or Nursing required and Master's Degree or other advanced degree preferred

• 5 or More Years Quality Assurance experience and or Clinical Operations involvement in regulated activities or equivalent experience required.

• 5 or More Years broad understanding of global expectations of Health Authorities in the management of clinical trials preferred

• 5 or More Years thorough and extensive knowledge of international GCP/GLP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance’s, and current industry practice preferred

• Proficiency in Mandarin Chinese (spoken and written) is highly desirable

• Ability to travel up to 20%

• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable

• Strong computer and database skills

• Attention to detail, accuracy and confidentiality.

• Clear and concise oral and written communication skills

• Excellent organizational skills

• Critical thinking, problem solving, ability to work independently.

• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.

• Communicate effectively and articulate complex ideas in an easily understandable way

• Prioritize conflicting demands.

• Work in a fast-paced, demanding and collaborative environment.

• Fluent in Madrin highly preferred yet not required.

This is the pay for this position

Pay Transparency

$158,000 — $185,000 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.

The company does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact the company’s Talent Acquisition team at  [link for members]  to obtain prior written authorization before referring any candidates to the company.

The company Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.