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:

The Associate Director, DP Commercial Small Molecule in External Supply Quality organization is responsible for ensuring the commercial small molecule products are manufactured, packed, labelled, stored and transported in a controlled way at CMOs that is in accordance with the regulatory expectations and applicable GMP/GDP quality standards. The role has global responsibility and accountability for commercial product quality for global supply. The scope will also include product life cycle management projects like dosage form changes, packaging changes and clinical supply after commercialization.

The job holder will support and ensure the compliance to applicable international regulations and BeiGene quality standards and procedures at CMOs.

The job location would be in US so that close to where CMOs are based.

The scope of the role will include but not limited to the following,

Small molecule commercial productsFor DP and FP stages at CMOManaging quality issues and changes at CMOsPost approval dosage form changes, packaging changes or other life cycle management projects, and clinical supply after commercialization

Essential Functions of the job:

Lead Small Molecule commercial product quality team to ensure the quality management process is in place and executed to ensure the product quality is compliant with regulatory requirements and BeiGene standards.Perform batch record reviewLead batch related deviation handling in investigation and effective CAPA implementation at CMOManage change controlsPerform batch dispositions Perform PIP (Person in Plant)Prepare batch related documents e.g. COAManage temperature excursion from storage and transportation.Ensure that quality processes meet Health Authorities expectation and continuously improve it by timely capturing related regulation changesAdvise and support Quality Agreement content, implementation, and updates.Obtain quality performance information at CMOs and drive continuous improvement. Provide the performance metrics information to CMO vendor management team and escalate any quality or compliance issue timely to senior management when needed.Closely collaborate with the CMO Vendor Management team on vendor performance monitoring and periodic review, support in audits as requiredWill work cross functionally and collaboratively in BeiGene with e.g. Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU.Provide quality support on product commercial supply e.g. timely batch release Support GCP inspections in IMP manufacturing perspectiveExecute product recalls from commercial supply chain when neededPerform other tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelinesWork with Clinical Product Quality, regulatory and CMC to establish Process Performance Qualification for Small Molecule productsAuthor Standard Operating Procedures related to function and departmentOversee the following investigations: nonconforming product, customer complaint, laboratory OOS and CAPA. Ensure all investigations are performed and closed in timely fashion

Supervisory Responsibilities:  

Responsible for management, development and co-ordination of a medium sized team of direct staff who are based in USAccountable for financial control and for the management of related budgets such as headcount related and travel.Ensures sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency.Build talent pipeline by inspiring and encouraging team members and create a great place to work for their personal development and career success.

Computer Skills:   

Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)

Qualifications:   

Bachelor of Science degree or above, in a related scientific discipline/technical filed such as Pharmacy, Biology, Chemistry or EngineeringMinimum 8 years pharmaceutical or biotechnology industry experience.8+ years of experience in quality with above 6 years management experienceIn-depth GMP experience in a quality and manufacturing function for small molecule oral solid dosage forms at DP and FP stagesAbility 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

Travel: 

May travel regionally and intercontinentally estimated up to 30%

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.

Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

Salary Range: $134,400.00 - $184,400.00 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.

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.