Sr. Manager, CMC QA

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.

1. Quality Management of CDMO /CMO Related to Project Development and Transfer Process and production process:

1) Be responsible for on-site supervision of project development, technology transfer and process validation and production process.

2) Be responsible for the review of materials and product related specifications and manufacturing process of CDMO/CMO entrusted products.

3) Be responsible for the review of related protocols and reports during R&D and transfer process. Including but not limited to: product process validation, equipment qualification, cleaning validation, analytical method validation, etc.

4) Be responsible for the acceptance and review of release data for drugs before production release and the preliminary review of records and reports of deviations, changes, CAPA, risk assessment and investigation of abnormal laboratory results related to the batch production process.

5)Participate in quality audits of CDMO/CMO.

2. Implementation and Maintenance of MAH Quality System:

1) Be responsible for archiving and managing product technical documents

2) Be responsible for improving the MAH's quality system SOP according to actual situation to ensure compliance and operability

3. Be responsible for the management of technical documentation for commercial products and quality management of production, ensuring products are manufactured compliantly and meet quality specifications.

• Familiar with pharmaceutical quality management system and be able to apply it flexibly, with at least 5 years of pharmaceutical quality assurance, 2 years quality control experience (chemical testing, conduct experiments).
• Experience and capabilities to deal with on site inspections from partner and health authority.
• Communication effectively with partners and health authority.
• Bachelor degree or above in pharmacy or related fields.
• Excellent communication skills in English.

• 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.

• Competitive Base Salary, Bonus, and Equity Plans
• up to 15 OPT and 12 Sick Days Annually
• Excellent Medical Coverage
• Social Security and Provident Fund
• 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.