Internal Application: Associate Director, Clinical Quality Assurance

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.

Position Summary:

Nuvation Bio is seeking a QA professional to join our Clinical Quality Team. You will prioritize and drive the strategy and success of pivotal projects partnering with cross-functional teams. You will work closely with all GxP functions as a thought partner and support management to lead Clinical Quality towards sustainable compliance.

Essential Duties & Responsibilities:

• Develops objectives and goals in alignment with company priorities and policies.
• Leads the implementation of quality standards, policies, and procedures in compliance with applicable ICH-GCP regulations and guidelines
• Assists in oversight of all GCP quality and compliance activities across the organization and ensures strategic alignment and close partnership with other GxP QA functions and development teams.
• Participates in cross-functional project teams and supports proactively GCP compliance by raising quality issues/events and assist in issue resolution, impact assessment and inspection readiness.
• Supports investigator site and sponsor inspection readiness activities including expertise before, during and post inspections & lessons learned as appropriate
• Assists in supplier quality management related activities, including external compliance and audit support of CROs, specialty laboratories for Phase I-III programs.
• Leads risk management activities (internal and external audits related to vendors, systems, documents, and functions; CAPAs and deviations) impacting key portfolio.
• Executes risk mitigation strategies, manage and/or assist with process improvement initiatives in close collaboration with business functions and provide consultation services and training.
• Collaborates with cross-functional teams, provide guidance and effective partnership to meet business priorities for adequate quality oversight
• Assigns projects, provides guidance, and manages KPIs to meet business priorities and assignments impacting internal and external stakeholders.
• Responsible for periodically gathering and reporting impactful data to senior management.
• Effectively manages priorities, multiple projects and ability to communicate with all levels of personnel.
• Assists in the budget planning process
• Other projects as assigned

Knowledge and Skill Requirements:

• BS in a related scientific field with 8-12 years of relevant experience in the biopharmaceutical/pharmaceutical industry.
• Previous Quality Assurance experience (5+ years) in clinical research /development preferred
• Minimum of 5-7 years of Quality Assurance auditing experience.
• Experience in developing/implementing Clinical Quality Assurance procedures.
• Strong knowledge of global GCP regulations, guidance, and standards.
• Experience at working both independently with minimal supervision and in a team-oriented, collaborative, environment.
• Ability to analyze issues and resolve in a compliant manner.
• Effective writing and oral presentation skills.
• Proficiency in MS Office applications (Word, Excel, PowerPoint, Project).
• Experience in GLP oversight is a plus.
• Experience with eQMS is a plus.
• Experience with GVP Quality is a plus.
• Travel requirement: 0-20%

Working Conditions:

• Physical Demands: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus
• Work Environment: The noise level in the work environment is usually moderate. Some travel may be required

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 pay range for this position is $XX,XXX to $XX,XXX per year, which may factor in various geographic regions. 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.