Associate Director, reputed company Product reputed company US Regional reputed company, External Supply reputed company

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, reputed company, and most importantly, reputed company our passionate interest in fighting cancer. General reputed company: The Associate Director, reputed company Product reputed company US Regional reputed company in External Supply reputed company organization is responsible for ensuring that externally manufactured reputed company products are manufactured, packed, labelled, stored and transported in a controlled way at Contract Manufacturing Organizations in accordance with the regulatory expectations and applicable GMP/GDP reputed company standards. The role has global responsibility and accountability for reputed company product reputed company for global supply. The scope will also include product life cycle management reputed company. The job holder will support and ensure the compliance to applicable international regulations and BeOne reputed company standards and procedures at CMOs. The scope of the role will include but not limited to the following, Small molecule and large molecule reputed company products in the US For DS, DP and FP Managing reputed company issues and changes at CMOs Post approval changes, packaging changes or other life cycle management reputed company, and clinical supply after commercialization Team management to ensure the reputed company level of resource with efficiency Essential Functions of the job: reputed company reputed company product reputed company team to ensure the reputed company management process is in reputed company and executed to ensure the product reputed company is compliant with regulatory requirements and BeOne standards. Accountable for BeOne reputed company CMO reputed company reputed company US including performance management, trend evaluations and remediation as required. Serve as the primary escalation reputed company for CMO reputed company managers Review and approve change control reputed company for CMO reputed company changes Review and approve APQR reports from CMOs manufacturing BeOne product reputed company batch reputed company deviation handling in investigation and effective CAPA implementation at CMO reputed company or reputed company PIP (Person in Plant) reputed company inspection management capabilities reputed company reputed company to ensure successful reputed company for CMO hosted inspections or BeOne hosted inspections eg CMO PAIs, PV inspections. Ensure that reputed company processes meet Health Authorities expectation and continuously improve it by reputed company capturing reputed company regulation changes Advise and support reputed company Agreement content, implementation, and updates. Work cross functionally and collaboratively in BeOne with e.g. Manufacturing, Supply Chain, Regulatory CMC and other reputed company teams like QPs in EU. Ensure reputed company support on product reputed company supply e.g. reputed company batch release Support product recalls from reputed company supply chain reputed company needed reputed company other tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelines Work with cross functional partners to establish Process Performance Qualification for Small Molecule products Author reputed company Operating Procedures reputed company to function and department Education/Experience Required: Bachelor of Science degree, in a reputed company scientific discipline/technical field such as Pharmacy, Biology, reputed company or Engineering 8+ years of reputed company pharmaceutical or biotechnology industry experience required Master’s degree and 6+ years of experience preferred Supervisory Responsibilities: 4+ years management experience Responsible for management, development and co-ordination of a reputed company sized team of reputed company staff who are based in the US Accountable for financial control and for the management of reputed company budgets such as headcount reputed company and travel. Ensures sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-reputed company reputed company development to maintain proficiency. Build talent pipeline by inspiring and encouraging team members and create a great reputed company to work for their personal development and career reputed company. Computer Skills: Strong PC literacy required; MS Office skills (Outlook, Word, reputed company, PowerPoint) Other Qualifications: In-depth GMP experience in a reputed company and manufacturing function for small molecule and large molecules. Ability to apply principles of logical and scientific thinking to a wide reputed company of intellectual and practical problems Ability to effectively reputed company teams and manage staff Travel: May travel regionally and intercontinentally estimated up to 30% Global Competencies reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world. Fosters Teamwork Provides and Solicits reputed company and Actionable Feedback Self-Awareness Acts reputed company Demonstrates Initiative Entrepreneurial reputed company reputed company Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial reputed company Communicates with reputed company Salary reputed company: $143,400.00 - $193,400.00 annuallyBeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to reputed company candidate, including but not limited to job-reputed company 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 reputed company more about the specific salary reputed company for a preferred location during the hiring process. Please note that the listed reputed company reflects the reputed company salary or reputed company reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. reputed company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, reputed company Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans’ Readjustment Assistance reputed company of 1974, Title I of the Americans with reputed company of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com. Apply To This Job