Associate Director, Quality Control Stability Administrator

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.

General Description :

Establish a stability program in Quality Control for clinical and commercial phase biologics products in accordance to FDA / EU regulations, applicable International Regulations and BeiGene processes and procedures. Oversee and manage stability studies to deliver scientifically sound GMP test data in accordance to predefined protocols. Oversee the Quality Control sample management program. Develop and implement quality control processes and procedures and support regulatory compliance inspections. Ensure the efficient and effective day to day running of the stability and sample management programs.

Essential Functions of the job :

• Establish and manage the QC stability program for clinical and commercial phase biologics products.
• Ensure timely completion of stability testing and generation of stability reports in support of regulatory submissions.
• Author stability study protocols and reports that are compliant with FDA / EU and ICH requirements.
• Establish, update, implement, and enforce Quality Control procedures and specifications consistent with cGMP, regulations, appropriate compendia, and BeiGene policies and standards.
• Coordinate with sample management and the testing laboratories to ensure stability time points are pulled and tested within the acceptable timeframes in accordance with approved study protocols.
• Create trend reports and assess study data to identify data anomalies, out-of-trends, and out-of-specifications.
• Lead laboratory investigations for data anomalies, out-of-trends, and out-of-specifications. Ensure appropriate CAPAs are implemented to prevent recurrence.
• Oversee the QC sample management program, including management of stability samples, on-test samples, retention samples, reference standards, and critical reagents.
• Manage the issuance and reconciliation of QC test records.
• Issue Certificates of Analyses (COA) to support batch disposition of manufactured products.
• Participate in internal and external GMP audits, as needed.
• Ensure all QC activities are performed in accordance with GMP regulations, company SOPs and Health and Safety policies.
• Managing, motivating, coaching and mentoring direct reports, to higher levels of management capability.
• Undertaking any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and / or an explanation has been provided and understood.

Core Competencies, Knowledge and Skill Requirements

Significant Contacts

Supervisory Responsibilities :

Computer Skills :

Education Required :

Bachelor or above of Science Degree in a related scientific discipline

Travel :

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Salary Range : $130,500.00 - $180,500.00 annually

BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA / HSA, Life Insurance, Paid Time Off, and Wellness.

Salary : $130,500 - $180,500