Associate Director Quality Assurance Compliance, Hopewell NJ Site

BeOne 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:

Responsible for the design, implementation, and management of Compliance programs for the Hopewell, NJ site.  Programs which require development under the QMS include, but are not limited to market action, self-inspection, Health Authority inspection preparation, annual reporting, deviation/complaint/CAPA management, and vendor qualification.  This position also includes successful day to day management of these systems post execution to support site clinical and commercial manufacturing.  The position may support other QA duties or QA projects assigned according to business needs.  Depending on the program supported, this position may include some travel.

Essential Functions of the job:

• Within the Quality Assurance organization, develop and implement Compliance programs for the Hopewell, NJ Site.  Ensuring the strategy meets the business requirements and customer deliverables, as well as ensuring the departmental performance against goals.
• Determining the appropriate quality KPI’s for clinical and commercial operations. 
• Working with vendors on as needed for Quality Assurance Agreement authoring and vendor qualification.
• Development of all necessary SOPs, ensuring regulatory compliance in conjunction with being appropriate both clinical and commercial operations.
• Ensuring that all activities are performed in accordance with GMP, SOPs and Health and Safety policies.
• Ensuring the availability of adequate competent resources to execute these QMS programs for commercial and clinical products.
• Developing a program for Deviation Management Excellence.
• Developing a program for Self-Inspection
• Ensuring appropriate investigation of discrepancies, errors, complaints, failures, or adverse events requiring documented review and action.
• Participation in regulatory and customer inspections/audits.
• Subject matter expert in GMPs: 21 CFR 210, 211, and 600; knowledgeable in EU Advanced Therapy Medicinal Products (ATMPs).
• Supervises, mentors, and coach’s direct reports, ensuring compliance and personnel development.
• Partner with operations to understand raw material, excipients, and component needs for clinical and commercial.
• Undertaking any other duties for any department within the business, which may be requested by the QA Senior Leadership.
• This is a site-based position.

• Scientific degree (ideally chemistry, biology, biotechnology, pharmaceutical sciences or related).
• Minimum of 8 years of experience in quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility are required.
• Minimum of 5 years of experience in people management.
• Deep knowledge in pharmaceutical QMS.
• Demonstrable track record and skills/experience gained within a similar position(s), at a similar level, specifically pertaining to vendor qualification, leading vendor audit programs, and vendor performance management.
• Wide knowledge of products and processes used in the manufacture of clinical and commercial manufacturing processes.
• Knowledge of both large and small molecules. 
• Strong personal leadership, ability to lead small teams.
• Good communicator (written and verbal) and strategic thinker, highly customer focused.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.
• Highly Desirable:  Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP.

• Interacts with BeiGene employees in Supply Chain, Technical and Operational departments frequently.
• Interacts with BeiGene Global Quality.

Supervisory Responsibilities:

• This position includes managing direct reports at the Hopewell, NJ site.

Computer Skills:

• Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint); knowledge of SAP QM module preferred, but not required.

Education Required:

Bachelor of Science Degree (or above) in a related scientific discipline

Travel:

• Must be willing to travel approximately 10% as needed.
• Ability to work on a computer for extended periods of time.

Global Competencies

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

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne 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 BeOne Medicines 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. BeOne 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].