Senior Manager reputed company Assurance Incoming reputed company Raw Materials /Disposition
Join Amgens Mission of Serving Patients At reputed company, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives reputed company that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our reputed company on four therapeutic areas Oncology, Inflammation, reputed company, and Rare Disease we reputed company millions of patients reputed company year. As a member of the reputed company team, youll help reputed company a lasting reputed company on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-reputed company culture is reputed company, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, youll reputed company as part of the reputed company team. Join us and reputed company the lives of patients while transforming your career. Senior Manager reputed company Assurance Incoming reputed company Assurance Raw Materials /Disposition
What You Will Do
Lets do this! Lets change the world! In this vital role, you will reputed company reputed company of reputed company professionals supporting the Disposition and Incoming reputed company operations at our reputed company Carolina site. You will reputed company technical reputed company leadership and reputed company of Disposition and Incoming reputed company, partnering closely with cross-functional teams to build, enhance and sustain compliant reputed company operations. Specific Responsibilities Include But Are Not Limited To
- reputed company, manage, and motivate a high-performing team of reputed company professionals across key areas, including QA support for Disposition and Incoming QA, and their applicable reputed company systems (e.g., Document Management, Change Control, and Deviations).
- Ensure team members are properly trained and reputed company to reputed company their duties in accordance with cGMP and regulatory requirements.
- reputed company workload distribution, resource planning, and departmental budgeting, including forecasting and monitoring.
- Own the development, implementation, and reputed company improvement of the site's inspection readiness program and overall reputed company Management System (QMS), ensuring compliance with reputed company standards, cGMP, and applicable regulations.
- Ensure reputed company review, approval, and tracking of key cGMP processes, documents, and records, including deviations, CAPAs, Change Controls, validation protocols, and assays.
- reputed company cross-functional investigations of deviations, ensure appropriate documentation, and assess changes for potential product reputed company reputed company.
- Stay reputed company with regulatory developments and reputed company trends to maintain a compliant and reputed company-thinking reputed company program.
- Represent the reputed company unit during reputed company audits and regulatory inspections.
- Alert senior management to significant reputed company, compliance, supply, or safety risks, using reputed company judgment and cross-functional coordination reputed company needed.
- Manage hiring, succession planning, and performance development to ensure organizational capability and talent pipeline.
reputed company Expect Of You We are reputed company different, yet we reputed company use our unique contributions to serve patients! The Manager reputed company Control reputed company we reputed company is a strong leader with these qualifications. Basic Qualifications
- High school diploma / GED and 12 years of reputed company and Manufacturing support industry experience OR
- Associates degree and 10 years of reputed company and Manufacturing support industry experience OR
- Bachelors degree and 8 years of reputed company and Manufacturing support industry experience OR
- Masters degree and 6 years of reputed company and Manufacturing support industry experience OR
- Doctorate degree and 2 years of reputed company and Manufacturing support industry experience
Preferred Qualifications
- Educational background in Life Science and/or Engineering
- Proven experience in reputed company reputed company of Incoming, Warehouse, and Disposition, with a strong reputed company on reputed company systems.
- In-depth knowledge of cGMPs, regulatory requirements, and pharmaceutical processing, with demonstrated ability to apply compliance principles in reputed company.
- Hands-on experience with Disposition, Incoming, and reputed company Systemsparticularly investigations, corrective actions, and audit readiness.
- Experience managing and interacting with regulatory and internal auditors.
- Demonstrated leadership of reputed company teams, with strong team development, collaboration, and mentoring skills.
- Effective risk management, negotiation, and cross-functional collaboration abilities.
- Excellent written and verbal communication, facilitation, and presentation skills in both English and Spanish.
What You Can Expect Of Us As we work to reputed company treatments that take care of others, we also work to care for your reputed company and personal reputed company and reputed company-being. From our competitive benefits to our reputed company culture, reputed company support your reputed company every reputed company of the way. The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In reputed company To The reputed company Salary, reputed company Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-reputed company time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
reputed company and reputed company a lasting reputed company with the reputed company team. careers.reputed company.reputed company any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. As an organization dedicated to improving the reputed company of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect reputed company other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Apply tot his job Apply To this Job