{"id":1102421,"url":"https://alion.io/job/beone-medicines-associate-director-quality-control-compliance","title":"Associate Director, Quality Control Compliance","company":{"id":99686,"name":"BeOne Medicines","domain":"beonemedicines.com","url":"https://alion.io/company/beonemedicines","size_band":"5000+","is_staffing_agency":false,"is_intermediary":false,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":28,"ghost_share":0,"stale_share":0.857,"repost_share":0,"time_to_fill_p50_days":33,"computed_at":"2026-09-23T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"hiring_geo_confidence":"structured","locations":["Hopewell, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":133800,"max":183800,"currency":"USD","period":"year","gross":null,"usd_annual":183800},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-09-21T00:00:00Z","employer_posted_date":"2026-09-21","last_verified_at":"2026-09-23T10:34:03Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"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.\nGeneral Description:\nThe Associate Director, QC Compliance will lead and manage all activities related to Quality Control lab compliance to ensure adherence to GMP guidelines in the manufacturing and testing of large and small molecule products. This role will focus on establishing QC compliance protocols, ensuring effective quality assurance processes, and maintaining regulatory compliance with FDA/EU regulations. The Associate Director will also support the development and implementation of compliance procedures and lead investigations related to compliance deviations. This role is located at the Hopewell, NJ site.\nEssential Functions of the job:\nDevelop, implement, and maintain Quality Control compliance programs in alignment with regulatory standards and internal policies. \nLead and manage laboratory investigations for Out of Specification (OOS), Out of Trend (OOT), and Other Exceptions (OOE) results, ensuring thorough evaluation and adherence to cGMP regulations. \nOversee the preparation and technical writing of compliance-related documents, including SOPs, compliance reports, deviation and CAPA records, and change control impact assessments. \nLead the establishment of a compliance monitoring program, including participation in internal and external GMP audits to ensure laboratory adherence to industry standards. \nCollaborate daily with Quality Assurance to maintain and improve the health of the quality management system. \nCollaborate cross-functionally with other departments including Regulatory Affairs, Manufacturing, and Quality Assurance to facilitate successful regulatory submissions and compliance initiatives. \nChampion a sustainable culture of quality, compliance, accountability, and continuous improvement across the QC organization. \nGuide and mentor QC compliance and review staff to enhance their capabilities, fostering a high-performing culture and promoting professional development. \nActively participate in risk assessments and assist in developing CAPA plans to tackle any compliance issues or potential risks efficiently. \nEnsure effective communication and training regarding compliance standards and regulatory expectations across the QC laboratory team. \nCore Competencies, Knowledge and Skill Requirements\nBachelor of Science degree and 8+ years of relevant working experience in an FDA-regulated biotechnology or pharmaceutical manufacturing environment required. \nMaster’s degree and 6+ years of related scientific experience preferred \n5+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources. \nExtensive knowledge of cGMP/EU GMP regulations and compliance, especially relating to large molecule manufacturing. \nStrong leadership and team management skills, with proven capabilities in mentoring and developing staff. \nExcellent analytical and problem-solving capabilities, with a track record of resolving complex compliance issues. \nHighly effective communicator, both written and verbal, capable of engaging with technical and non-technical stakeholders. \nStrong project and program management skills with experience directing multiple priorities within a fast-paced environment. \nAttention to detail and commitment to producing quality work, with the ability to work proactively and independently. \nSupervisory Responsibilities:\nManage and mentor a dedicated team of 1-2 QC compliance professionals, including data reviewers. \nComputer Skills:\nStrong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint) \nExperience with Veeva and ThermoScientific LIMS is a plus \nTravel:\nMust be willing to travel approximately 20% \nAbility to work on a computer for extended periods of time \nGlobal Competencies\nWhen 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.\nFosters Teamwork\nProvides and Solicits Honest and Actionable Feedback\nSelf-Awareness\nActs Inclusively\nDemonstrates Initiative\nEntrepreneurial Mindset\nContinuous Learning\nEmbraces Change\nResults-Oriented\nAnalytical Thinking/Data Analysis\nFinancial Excellence\nCommunicates with Clarity\nSalary Range: $133,800.00 - $183,800.00 annuallyBeOne 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.\nWe 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 .","description_format":"text","description_chars":6511,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Continuous learning","Equity","Life insurance","Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Clinical Research"],"lifecycle":[{"event":"open","at":"2026-09-22T00:37:54Z"}],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":2,"expected_fill_days":33,"reasons":["conf:1","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-09-23T05:45:00Z"},"pay":{"stated_usd_annual":183800,"is_top_pay":false},"html_url":"https://alion.io/job/beone-medicines-associate-director-quality-control-compliance","json_url":"https://alion.io/job/beone-medicines-associate-director-quality-control-compliance.json","meta":{"generated_at":"2026-09-23T12:26:07Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers"}}