Who we are…
Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.
What you’ll be doing
Nuvation Bio is seeking Quality Assurance expert to join our Quality Team. The Associate Director of Quality Assurance position provides QA oversight for contract manufactures, laboratories and GMP service providers. This will include batch release, auditing and quality oversight ensuring that the quality systems and controls meet Nuvation Bio’s standards and regulatory requirements for commercial and clinical product release, shipment and distribution.
You will be responsible for…
- Provides quality oversight for Commercial Quality life cycle management
- Assists in the change control process and performing final Quality Review
- Responsible for the quality oversight and execution of chemistry, manufacturing, and control (CMC) related activities for drug candidates through all stages of clinical development to global commercialization for a specific program(s)
- Provide quality and compliance support of pharmaceutical development in an outsourcing environment for drug substance (DS), drug product (DP), clinical trial material (CTM) and commercial product, including the quality aspects of the process and formulation development, manufacturing, analytical testing, packaging, labeling, product release, distribution, and associated stability programs as assigned
- On the assigned program, responsible for ensuring drug substances and drug products are manufactured in compliance with cGMP and consistent with applicable regulatory filings
- Approve master 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
- 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 the finished product
- For assigned program(s) will review and approve analytical, stability, and validation documents including protocols, methods, data, and final reports
- Support the qualification, performance tracking, and reviews of contract manufacturers, suppliers, and laboratories as needed. Support 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 specific manufacturing and testing organizations (CMOs and test labs) are operating in a manner that is consistent with regulations and internal policies.
- Manage quality investigations/audits at contract manufacturers to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective action
- Manage and lead resolution of Product Quality Complaint
- Collects, trends and reports Quality related KPIs (Key Performance Indicators) to be reported to Management
- Remain current in regulatory trends and requirements
What Knowledge & Experience you'll bring to us...
- Bachelor's degree in life sciences from 4-year college or university
- 10 years or progressive, challenging QA/QC experience in the pharmaceutical or related industry
- Excellent knowledge of current GMP and GLP as well as FDA trends and guidelines
- Prior experience in commercial product quality lifecycle management, release and complaint management
Behavioral skills to be successful...
- Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
- Emotional intelligence , curiosity, and a knack to figure out a way to build something better
- Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
- Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
- Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.
What we have for you!
- Competitive Base Salary, Bonus, and Equity Plans
- Unlimited Vacation and 10 Sick Days Annually
- Excellent Medical, Dental, and Vision Coverage
- 401K with Company Matching
- and much more!
The base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
Disclaimer
Nuvation Bio, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Note to all external Recruiters & Staffing Agencies
All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.
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