BeOne Medicines · 1 day ago
Associate Director, QC Operations, US Site (Hopewell, NJ)
Hopewell, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
$134K/yr - $184K/yr
8+ years expBeOne Medicines is a rapidly growing company focused on fighting cancer, seeking an Associate Director of Quality Control. The role involves leading analytical strategy and QC operations to support GMP testing and product release while ensuring compliance with regulatory standards through strong cross-functional collaboration.
Pharmaceuticals
Responsibilities
Develop and oversee quality control (QC) procedures and programs for Good Manufacturing Practice (GMP) testing and product release
Lead and conduct laboratory investigations for Out of Specification (OOS), Out of Trend (OOT), and Out of Expectation (OOE) results, including the authorship of technical documents such as Standard Operating Procedures (SOPs), Test Methods, and Validation Protocols/Reports
Manage assay development, qualification, and technical transfer processes for both internal and external vendors
Provide technical guidance and written support for Investigational New Drug (IND) submissions and other regulatory documentation
Coordinate and schedule analytical testing, ensuring thorough review and approval of test records, Certificate of Analysis (COA), and final reports
Train and supervise laboratory personnel, effectively managing direct reports to foster a high-performing team
Support troubleshooting during method transfers and validation studies, while authoring, reviewing, and approving experimental protocols, validation reports, test methods, and technical memos/reports
Guide the team in data analysis and trending to evaluate results and draw actionable conclusions to support decision-making
Ensure that all documentation is completed accurately, timely, and in compliance with regulatory standards
Provide decisive leadership and operational expertise to drive quality and efficiency within the QC department
Collaborate cross-functionally within the organization to shape product life-cycle timelines and support synthesis and formulation divisions effectively
Facilitate successful technology transfer between internal departments and external partners, including ARD, TPL, and Contract Manufacturing Organizations (CMOs)
Establish and maintain a working environment that attracts and retains top talent, promotes ongoing staff development, and recognizes individuals with high potential in both technical and managerial roles
Qualification
Required
Bachelor's degree in Biology or related field and 8+ years of experience in analytical sciences and GMP/GLP environments; Master's degree preferred
Minimum 5 years of managerial experience leading teams and projects
Expertise in Chemistry or other closely related disciplines with 5+ years relevant work experience in pharmaceutical industry
Strong understanding of GMP/GLP regulations
Excellent project management and cross-functional collaboration skills
Hands-on experience on analytical team building with strong problem-solving skills
Conversant with ICH guidelines, applicable law and regulations of major markets (China, US, EU, Japan, etc.), and other compendial requirements (USP, EP, ChP etc.)
Experienced in CMC document preparation for IND and NDA filing
The candidate should be a very effective communicator, interacting with key stakeholders, regulators and other technical lines and matrix teams
Strong written and communication skills and an ability to work effectively with a diverse team of co-workers in a dynamic environment
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeOne Medicines
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide.
10001+ employees
H1B Sponsorship
BeOne Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
Funding
Current Stage
Late StageCompany data provided by crunchbase