Associate Director Quality Assurance Compliance, Hopewell NJ Site Join to apply for the Associate Director Quality Assurance Compliance, Hopewell NJ Site role at BeOne Medicines Associate Director Quality Assurance Compliance, Hopewell NJ Site Join to apply for the Associate Director Quality Assurance Compliance, Hopewell NJ Site role at BeOne Medicines 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. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. 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.

Is this your next job Read the full description below to find out, and do not hesitate to make an application.

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.

Core Competencies, Knowledge, and Skill Requirements

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.

Significant Contacts

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

Salary Range: $137,200.00 - $187,200.00 annually

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 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. 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.Seniority level Seniority levelMid-Senior level Employment type Employment typeFull-time Job function Job functionQuality Assurance Referrals increase your chances of interviewing at BeOne Medicines by 2x Sign in to set job alerts for “Director of Quality Assurance” roles. Princeton, NJ $186,000 - $233,000 1 day ago Cranbury, NJ $150,000 - $180,000 2 weeks ago Executive Director/VP Quality and Regulatory Bridgewater, NJ $171,000 - $239,667 1 day ago Senior Quality Assurance Manager - Sterile ProductsDirector of Quality Assurance - Aseptic CDMO New Jersey, United States $450,000.00 - $650,000.00 1 month ago Director External Quality, Advanced Therapies Raritan, NJ $146,000.00 - $251,850.00 2 days ago Food Safety & Quality Assurance Director- Woodstock FarmsSenior Manager - North America Operations Quality PV Oversight Plainsboro, NJ $170,000.00 - $200,000.00 2 days ago Director External Quality, Advanced Therapies Horsham, PA $146,000.00 - $251,850.00 2 days ago Food Safety & Quality Assurance Director- Woodstock Farms Trenton, NJ $100,000.00 - $105,000.00 2 days ago Basking Ridge, NJ $206,025.00 - $343,375.00 4 days ago Associate Director of Quality - Process AnalyticsManager, MISE Vendor and Quality Management Titusville, NJ $115,000.00 - $197,800.00 2 days ago Senior Manager - North America Operations Quality PV Oversight Plainsboro, NJ $170,000.00 - $200,000.00 3 weeks ago Associate Director, External Data Quality Manager Plainsboro, NJ $157,120.00 - $235,680.00 2 weeks ago Basking Ridge, NJ $206,025.00 - $343,375.00 5 days ago Princeton, NJ $120,000.00 - $170,000.00 1 week ago Director of Patient Safety and Quality, InpatientAssociate Director, Procurement, Cell Therapy - Direct MaterialsAssociate Director, Procurement, Cell Therapy - Direct Materials Princeton, NJ $175,000.00 - $225,000.00 4 weeks ago Asst Director Patient Care - Nights - Labor & Delivery Somerville, NJ $99,840.00 - $137,280.00 1 day ago New Jersey, United States $150,000 - $180,000 3 weeks ago Princeton, NJ $100,000 - $125,000 1 week ago East Windsor, NJ $100,000 - $120,000 3 months ago Senior Manager, Program Management (CMC, Quality)Quality Manager - Metals - Piscataway, NJ Piscataway, NJ $75,000 - $100,000 1 week ago High Bridge, NJ $110,000 - $135,000 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr