Quality Compliance, Senior Manager at Amigen

Thousand Oaks, California, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Feb, 26

Salary

164599.0

Posted On

17 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Compliance, Audits, Regulatory Requirements, Risk Assessments, Training, Leadership, Communication, Technical Support, Inspectional Commitments, Continuous Improvement, Drug Substance, Drug Product, Medical Device, Combination Product, Active Pharmaceutical Ingredients, Small Molecule

Industry

Biotechnology Research

Description

Career Category Quality Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Quality Compliance Senior Manager What you will do Let’s do this. Let’s change the world. Let’s do this. Let’s change the world. In this vital role you will be responsible for driving Global Quality Compliance Audits and assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities: Coordinates, leads, or participates in Corporate Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers, to assess compliance with all applicable regulations and to identify top compliance risks. Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies. Implements risk assessments. Ensure completion, maintenance and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to regulations, guidelines and standards, trends and expectations, as applicable). Has documented experience and working knowledge of Amgen’s competencies including but not limited to manufacturers or intermediates, API/drug substance, drug product, combination products, medical devices, and laboratories. Provides leadership toward calling out site and multi-site compliance issues resulting from audit findings. Serves as subject matter expert on global regulated requirements and inspectional commitments, as applicable. Provides support for domestic and international Regulatory Authority Inspections when necessary. Provides technical support/compliance review of multi-site/global documents resolving compliance issues, if/when necessary. Interacts with other functional leads to ensure that Amgen Standards, strategies and direction are aligned with existing regulations and regulatory expectations. Alerts senior and/or executive management of significant quality, and compliance risks. Provides support for audit and inspection metrics as vital. Supports Continual Improvement initiatives, programs and projects. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The compliance professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree and 2 years of compliance experience OR Master’s degree and 4 years of compliance experience OR Bachelor’s degree and 6 years of compliance experience OR Associate’s degree and 10 years of compliance experience OR High school diploma / GED and 12 years of compliance experience Preferred Qualifications: Lead Auditor Certification Audit Experience in Drug Substance (DS), Drug Product (DP), Finished Drug Product (FDP), Medical Device, Combination Product, and/or Active Pharmaceutical Ingredients (API), and Small Molecule Strong communication skills both verbal and written Domestic and International travel up to 50% What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range 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 addition to the base salary, Amgen 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 vision 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-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In 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. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis 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 perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 141,158.00 USD - 164,599.00 USD Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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Responsibilities

The Senior Manager will drive Global Quality Compliance Audits and manage projects to achieve corporate goals. This includes assessing compliance, implementing risk assessments, and providing leadership on compliance issues.