Director, QA Computer System Validation

1 month ago

New York, United States Nuvation Bio, Inc. Full time
Job DescriptionJob DescriptionWho 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 a data integrity and computer system validation expert to join our Quality Team. You will set the strategy and oversee our approach to data integrity, data governance and computer systems validation, partnering with cross-functional teams across the business. You will work closely with cross-functional teams as a thought partner, and to ensure system compliance, advise on data processes, and provide audit support as needed.

You will be responsible for…
  • Provide leadership and expertise in the interpretation, development, and implementation of global policies to ensure initial and on-going compliance of digital systems with cGMP, 21 CFR Part 11, Annex 11, and GAMP requirements.
  • Collaborate with corporate functions to ensure continuous and verifiable compliance throughout the entire GMP digital environment and lifecycle.
  • Support the overall readiness of the CSV program and computer-related systems to ensure software programs are compliant and ready for audits and regulatory inspections.
  • Review/assess proposed GXP-related computer system change controls, investigations, CAPA, periodic reviews of GXP systems and system access in alignment with procedures to ensure compliance.
  • Review and approve validation plans, protocols, reports and other verification/validation related documentation for GXP computer systems.
  • Assess systems for data integrity and compliance with regulatory expectations including assessment of third-party IT service suppliers and applications.
  • Participate in and support the external audit program for vendors related to GXP computerized systems.
  • Provide QA guidance in the development and revision of GXP computer system procedures.
  • Participate in cross-functional project teams in support of GXP computer system compliance.
  • Work in collaboration with the system owners and administrators, to address priorities for programs and changes to GXP Computer system configuration, security, security profiles and any required migration plans for compliant implementation in alignment with organizational processes.
  • Perform quality support duties including implementation, maintenance, and execution of quality management system processes in the Veeva.
  • Provide ongoing Quality support, advice, and guidance to GXP related System Owners and System Administrators.
  • Effectively manage priorities, multiple projects and ability to communicate with all levels of personnel.
What Knowledge & Experience you'll bring to us...
  • Degree in Scientific discipline, Computer Science, or Information Technology
  • Minimum 10+ years of progressive pharmaceutical experience in GxP computer systems validation, software validation
  • Experience leading change management and integration efforts in the pharmaceutical industry and quality organization preferred
  • Experience in EDMS, LMS, e-QMS and ERP implementation and lifecycle management
  • Global experience with multi-functional teams strongly preferred
  • Proven experience as an effective collaborator and leader
  • Experience creating policies and procedures focused on data integrity and computer systems validation
  • Experience creating and presenting project plans, trainings and other presentations for leadership
  • Must be able to travel domestically up to 20% with occasional international as well
  • Candidates located in SF Bay Area or NYC Metro area preferred
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 $175,000 to $200,000 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.

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