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:
- Managing and reviewing new supplier requests
- Managing, reviewing, and finalizing questionnaires
- Purchasing, reviewing, and reporting on third-party audit reports
- Reviewing, approving, monitoring, and closing vendor audit commitments
- Managing, reviewing, approving, and monitoring vendor periodic assessments
- Leading cross-site vendor periodic assessments
- Performing internal and vendor audits
- Reviewing, approving, monitoring, and closing internal audit responses and CAPAs
- Facilitating the review and approval of vendor and BeiGene cross-site quality agreements
- Perform other duties as assigned
Essential Functions of the job:
- Support Global vendor management program, including generation and maintenance of GMP Global Vendor audit schedule
- Prepare and maintain GMP vendor risk management program. Perform vendor risk
- assessments to determine and evaluate audit frequency
- Work with Global Supplier Management to ensure accuracy of supplier data across BeiGene network sites; perform supplier periodic reassessments / qualifications.
- Support the process of Quality Agreement implementation and updates
- Assess, approve, manage audit finding response plans/CAPAs and assess corrective measures for internal and external GMP Compliance audits.
- Lead or participate in meetings pre and post audit to discuss and drive to closure unresolved issues with auditees, stakeholders or Senior Management.
- Work with Global Supplier Management to ensure accuracy of supplier data across BeiGene network sites; perform supplier periodic reassessments / qualifications.
- Provide Quality guidance and support for investigations and change controls
- Provide Quality Compliance guidance of cGMP external manufacturing operations (CMO) as necessary
- Support health authority inspections and partner audits
- Support the process of Quality Agreement implementation and updates
- Assess and revise, as needed, SOPs for GMP Quality functions and identify opportunities to streamline systems and processes
- Perform duties as assigned to ensure compliance to global and local regulations
Core Competencies, Knowledge and Skill Requirements
- GMP internal, corporate, or supplier auditing
- In-depth knowledge of Quality principles, concepts, industry practices and standards
- In-depth and working knowledge of cGMP regulations and experience with regulatory compliance inspections (US Code of Federal Regulations, Title 21, Parts 11, 210, 211; Chinese GMP 2010, EudraLex Volume 4 GMP Guidelines, ICH, WHO, as well as other regulations).
- Ability to work independently with scientific/technical personnel
- Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior team member and to engage and influence team
- members in a matrixed environment.
- Knowledge of risk management tools and computer systems validation a plus.
- Ability to work in a global setting
- Self-supervised.
Communication & Interpersonal Skills
- Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail
Significant Contacts
Interacts with all levels of BeiGene employees including CMOs and suppliers
Experience
- Requires a minimum of 5+ years’ experience in pharmaceutical, biologics, or biotechnology industry, with 2+ years experience as a GMP auditor
Education Required: Bachelor degree with 5+ years of experience or Masters with 4+ years of experience
Computer Skills:
Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Other Qualifications:
- Spoken/Written fluency in English required
- Strong project management skill set
Travel:
- Ability to work on a computer for extended periods of time
- Must be able to travel domestically and internationally
Competencies:
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.
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.
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.
Salary Range: $104,400.00 - $144,400.00 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.
Please Note :
bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.