Job Title: Senior Director, Quality Assurance

Department: Quality

Location: Miami/Remote

Overview of Role:

The Senior Director of Quality Assurance will report to the Vice President, Quality Assurance and Regulatory CMC, and will be focused on ensuring GMP compliance to drug substance and drug product manufacturing process and ensure inspection readiness at all times. This role will lead all quality activities supporting Summit’s products and oversee the development, implementation and maintenance of quality assurance systems and activities, and lead and build the quality team and function. The Senior Director will focus on readiness for BLA filing, PLI readiness, drug approval, and commercialization and function as the QA lead for handling commercial drug quality complaint handling and resolution including investigating for Field Alerts.

Role and Responsibilities:

• Develop and implement GMP quality systems including all quality policies and procedures conduct risk assessments, develop and implement risk-mitigations and potential process improvement pertaining to GMP manufacture and testing in accordance with ICH, FDA, EMA and other global Health authority regulations and industry standards
• Responsible for providing sponsor oversight of Contract Manufacturing Organizations (CMO) to support clinical and commercial manufacture
• Lead and ensure GMP inspection readiness activities for Summit and external CMOs and manage all regulatory inspections in collaboration with relevant stakeholders
• Mentoring other individuals within the organization in the area of compliance
• Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions as appropriate
• Establish internal QA batch review and release processes for batch disposition of drug products as required and in compliance with applicable regulations
• Supervise and guide internal audits of departments and processes
• Review existing policies and procedures, and develop new and enhanced policies that ensure compliance to regulations
• Write, revise, review and/or approve SOPs, controlled documents to ensure compliance with all applicable regulations
• Drive cross-functional collaboration and alignment with other departments, and stakeholders to achieve quality and compliance objectives
• Develops a robust quality system and fosters best practices across the organization
• Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met
• Establish and maintain performance metrics
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s degree in chemistry, biochemistry, life sciences or biotechnology; higher degree preferred
• 15+ years of relevant experience in the pharmaceutical industry with atleast 8+ years experience in commercial manufacturing of drug substance and drug product
• Biologics experience is essential. Working knowledge in analytical laboratory testing is a plus
• Experience in the use of e-QMS to effectively execute quality systems such as MasterControl or TrackWise
• Strong expertise and experience with GMP manufacturing requirements for clinical and commercial biologics
• Demonstrated ability working with and managing CMOs
• Experience in designing and implementing quality systems and risk management tools
• Experience leading/hosting US and international health authority inspections
• Experience managing complex business relationships with QPs
• Excellent communication skills both oral and written.
• Fluency is mandarin is highly preferred
• Experience in working independently on multiple programs in a fast-paced environment with and able to balance changing priorities
• Attention to detail, self-motivated with a strong sense of work ethic
• Excellent interpersonal skills and collaborative

The pay range for this role is $220,000-$250,000 annually. 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 successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with up to a 15% discount up to the federal limit, flexible spending account among other benefits.

Summit 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 Summit’s human resources department to obtain prior written authorization before referring any candidates to Summit.