BeiGene Director, Head of Global QC in Helena, Montana
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
The Director, Head of Global QC is responsible for overseeing QC activities and projects related to CMOs for small molecule and large molecule. Develops, interprets, and implements quality control policies and procedures, and supports regulatory compliance inspections. Manages QC activities (include global pharmacopoeia monitoring, analytical method transfer, routing testing data review, trending and stability programs, OOS investigation,) that support GMP manufacturing, testing and release of finished products under NMPA/FDA regulations, applicable International Regulations, ICH standards, and BeiGene processes procedures.
Essential Functions of the job :
Supports development and management of QC activities/program, systems, policies, procedures and controls to ensure that BeiGene owned products conform to established specifications.
Provides oversight of CMO testing activities, including analytical testing, laboratory investigations, protocol and report development and review, stability testing, reports, and investigations with global partners.
Ensuring data integrity compliance with the current Regulatory Guidance for all QC Quality Systems in Quality Control Operations.
Monitor industry requirements to ensure QC processes, such as real time data trending, reliable and efficient data extraction for periodic reporting, and assessment of the suitability of existing systems to perform intended functions, are adequate.
Leads global pharmacopoeia monitoring process.
Leads deployment activities for select global external standards/regulations impacting QC Quality Systems.
Leads analytical methods transfer to third party laboratory globally.
Work with Analytical Research and Development in the development and execution of method maintenance strategies for continuous improvement to address outdated software, equipment, and methodology.
Work with regulatory to author and review pertinent sections of an NDA/BLA application.
Work with regulatory in providing technical responses to FDA quires.
Author Standard Operating Procedures related to global QC activities.
Core Competencies, Knowledge and Skill Requirements
Minimum of master’s degree in chemistry/biology or related scientific discipline.
Minimum of 15 years’ experience in pharmaceutical/biological drug product development, analytical chemistry and/or quality control in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required.
Minimum of 8 years’ experience in management, with training and knowledge of Data Integrity Guidance and Data Management Systems utilized in a Quality Operation.
Minimum of 8 years in direct supervision of laboratory staff or project management. Experience in conducting analytical investigations on small molecule and large molecule.
Communication & Interpersonal Skills
- Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail.
- Interacts with all levels of BeiGene employees; CMOs.
15+ years of experience in pharmaceutical industry
10+ years of experience in ARD/QC role, 8 of which includes management experience.
Strong knowledge and experience with GxP regulations and Data Integrity Guidance
Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems.
Ability to effectively lead teams and manage staff
- Manage direct reports globally
Education Required: Master or above of Science Degree in a related scientific discipline
- Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Travel for Work:
Must be willing to travel approximately 30%
Ability to work on a computer for extended periods of time
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with BeiGene’s Code of Business Conduct and Ethics, policies and procedures.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Completes administrative tasks correctly and on time; Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations; Writes clearly and informatively; Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed; Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions and responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and within budget.
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.