Manager, Global QC, Project and Technology

BeiGene, Ltd.; United States; Remote; USD 108,000 - 149,000; Full time

Job summary

An established industry player is seeking a dedicated Manager for Global QC to lead analytical development and quality control activities. This role involves managing QC processes at Contract Manufacturing Organizations, ensuring compliance with global regulations, and fostering collaboration across teams. Ideal candidates will have extensive experience in pharmaceutical testing, strong leadership abilities, and a proactive approach to problem-solving. Join a forward-thinking organization committed to fighting cancer and making a significant impact in the field. This position offers a dynamic work environment with opportunities for professional growth and development.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Flexible Spending Account (FSA)

Health Savings Account (HSA)

Life Insurance

Paid Time Off (PTO)

Wellness Programs

Qualifications

• 5+ years' experience in FDA-regulated pharmaceutical company.
• Expertise in analytical and microbial testing.

Responsibilities

• Manage and support analytical development and QC activities.
• Perform QC review on specifications and analytical records.

Skills

Pharmaceutical Analytical Testing

Microbial Testing

Project Management

Leadership

Communication Skills

Problem-Solving

Time Management

Education

Bachelor's Degree in a Related Scientific Discipline

PhD in a Related Field

Tools

MS Office

Job description

Manager, Global QC, Project and Technology

Apply locations: Remote (US)

Time type: Full time

Posted on: Posted 10 Days Ago

Job requisition id: R28880

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. During this transition, "BeiGene" or "BeOne" may be used to describe the company. BeOne continues to grow rapidly, offering challenging and exciting opportunities for experienced professionals. We seek scientific and business professionals who are highly motivated, collaborative, and share our passionate interest in fighting cancer.

General Description:

Manages and supports analytical development and QC activities at designated Contract Manufacturing Organizations (CMOs). Acts as a QC representative to review and approve technical documents such as stability reports, analytical procedures, and record reviews. Supports product development and global launches by serving as an analytical/QC SME in method qualification/validation/transfer, specification development, stability studies, shelf-life updates, and change control. Aims to improve analytical/QC systems and processes globally.

Essential Functions:

1. Perform QC review on specifications, analytical records, CoAs, stability protocols, reports, and other technical documents.
2. Manage stability studies at CMOs.
3. Oversee method transfer and validation activities, including strategy, protocols, and reports.
4. Engage proactively with QC counterparts at CMOs.
5. Support CMC activities at CMOs as needed.
6. Provide QC oversight on development and commercial projects.
7. Ensure compliance with BeOne SOPs.
8. Support implementation of Global Quality Systems and Standards.
9. Assess and revise SOPs for GMP Quality functions, identifying opportunities for streamlining.
10. Ensure compliance with global and local regulations.

Core Competencies and Requirements:

• 5+ years' experience and 2+ years' team management in an FDA-regulated pharmaceutical company.
• Expertise in pharmaceutical analytical and microbial testing and equipment.
• Knowledge of USP/EP and cGMP/EU GMP standards.
• Knowledge of analytical methods and electronic systems.
• Strong leadership and team management skills.
• Effective communication skills at all levels.
• Analytical and problem-solving skills.
• Excellent project management skills.
• Hands-on with a proactive, 'can do' attitude.
• Good time management and prioritization skills.

• Attention to detail, accuracy in a busy environment.
• Self-motivated, proactive learner.
• Dedicated to ongoing learning and development.

Significant Contacts:

• Interacts with all levels of BeiGene employees, CMOs, and suppliers.

Project Management: Communicates changes and progress; completes projects on time and within budget.

Computer Skills:

• Proficiency in MS Office (Outlook, Word, Excel, PowerPoint).

Qualifications:

5+ years' experience with a Bachelor's degree in a related scientific discipline, or 4+ years with an above-degree, or 2+ years with a PhD.

Travel:

• Willing to travel approximately 5%.
• Ability to work extended hours on a computer.

Global Competencies:

Exhibiting values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit through competencies like teamwork, feedback, self-awareness, inclusivity, initiative, entrepreneurial mindset, continuous learning, adaptability, results orientation, analytical thinking, financial excellence, and clear communication.

Salary Range: $108,100 - $148,100 annually.

BeiGene is committed to fair, equitable pay, with packages determined by skills, experience, education, and location. Compensation may include bonuses, equity awards, and participation in stock purchase plans. Benefits include medical, dental, vision, 401(k), FSA/HSA, life insurance, PTO, and wellness programs.

We are an equal opportunity employer valuing diversity. Employment decisions are based on qualifications, merit, and business needs, without discrimination based on race, religion, gender, age, disability, or veteran status.