Director/Senior Director, CMC Quality Assurance

ESSENTIAL JOB FUNCTIONS:

• This position will be responsible for the oversight and execution, from a quality perspective, of chemistry, manufacturing and control (CMC) related activities for drug candidates through all stages of clinical development to global commercialization. Key accountabilities include contribution to development, implementation and maintenance of the company’s CMC quality assurance program to ensure regulatory compliance of all external GMP vendors (CMOs, CROs).
• Ensure implementation and maintenance of quality systems including but not limited to SOP writing, document control, audit programs, batch record review, deviations, change control and technical report review
• Provide quality and compliance oversight of pharmaceutical development in an outsourcing environment for drug substance (DS), drug product (DP) and clinical trial material (CTM), including the quality aspects of process and formulation development, manufacturing, analytical testing, packaging, labeling, product release, distribution and associated stability programs
• Manage and support all quality activities related to the manufacturing and release of clinical product including resolution of investigations and quality issues
• Responsible for ensuring that all drug substances and drug products are manufactured in compliance with cGMP and consistent with applicable regulatory filings
• Perform quality assurance activities to ensure timely delivery of DS, DP and finished (packaged and labeled) product to support the clinical development plan, as well as the commercial sales plan as appropriate
• Review and evaluate Batch Production and QC Control Records for API and Drug Product data to ensure all approved procedures were followed and all specifications were met, including data generated by different functions, and accordingly approve the final disposition and release of finished product
• Review and approve analytical, stability and validation documents including protocols, methods, data and final reports
• Review and approve batch records for all labeling and packaging operations. Ensure proper version control and document integrity of packaging component labeling, specifications, printed labeling artworks and other assigned labeling documents
• Oversee qualification, performance tracking, and reviews of contract manufacturers, suppliers and laboratories. Oversight to include confirmation of compliance, management of quality audits and inspection readiness activities, and appropriate resolution of corrective and preventive action plans, as required. Ensure manufacturing and testing organizations (CMOs and test labs) are operating in a manner that is consistent with regulations and internal policies
• Manage quality investigations at contract manufacturers to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions
• Track non-compliance events that occur during production and testing, investigate and support remediation, as required
• Provide Quality Control of documents in support of regulatory submissions (i.e. CMC sections for INDs and NDAs, to FDA as well as foreign regulatory authorities) for investigational products, market applications and periodic updates
• Ensure documents and records are kept in compliance with regulations and SOPs
• Assure that source data and information used in our regulatory submissions and validation activities is maintained and traceable
• Define and maintain the external audit schedule, manage the coordination and preparation of audits, execution of the audit, the audit report, and follow up to any finding and ensure any violations are corrected and sustained
• Prepare for FDA preapproval onsite inspections and represent the company during inspections
• Establish/maintain effective relationships with vendors to assist with the inspection and evaluation of Quality Unit (QU) business model for moving to Phase 3 and Commercialization
• Identify potential QA risks to the strategic/operational plans and propose options to mitigate risks
• Propose quality improvements to Quality Systems to maintain compliance and improve efficiency as part of continuous improvement initiatives

JOB SPECIFICATIONS:

• Bachelor degree in a Life Sciences discipline or equivalent
• 10 plus years of relevant experience in a regulated biotech, or pharmaceutical industry in a Quality Assurance function
• Experience in late stage/commercial pharmaceutical projects with a strong track record of successful NDA and EMA filings
• Experience with the CMC and Regulatory Filing requirements
• Experience with implementing and maintaining pharmaceutical quality systems which ensure compliance to GMP and regulatory standards.
• Experience in managing, hosting or supporting FDA, EMA or other regulatory agency inspections
• Working knowledge of drug development process and GMPs, FDA/EMA/ICH guidelines and practical experience in auditing practices and procedures
• Working knowledge of preparation and submission activities, specifically in relation to CMC, for regulatory filings in USA, EU and Rest of World.
• Demonstrated project management experience and skills, with the ability to coordinate multiple projects in a demanding, fast-paced environment.
• Demonstrated audit conduct and management experience
• Excellent oral and written communication skills for effectively interfacing with other departments within the company, suppliers, and other contractors
• Exceptional mental agility, strong executive presence, strategic aptitude, and a sense of urgency to “make things happen”
• Ability to work with all levels of the organization and external contract service providers to ensure compliance with current regulations
• Ability to travel for both domestic and international business

PHYSICAL DEMANDS:

While performing the duties the employee is:

1. constantly required to sit, and to reach to use computers and other office equipment
2. occasionally stand for extended periods of time, up to four (4) hours/time.
3. occasionally required to lift up to 10 pounds
4. constantly required to view objects at close and distant ranges
5. frequently required to communicate with others

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the workday, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

WORK ENVIRONMENT:

Employee frequently works in a professional office environment and lab with lots of computer equipment, tools, and moderate amounts of noise and activity. Employee may occasionally be required to travel. The work environment is fast-paced and demanding. Off-shift, weekend and overtime duties may be required as assigned by the manager.

Kura Oncology is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package. To apply, please submit your resume to careers@kuraoncology.com