GCP Quality Compliance Manager

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

GCP Quality Compliance Manager

What you will do

Lets do this! Lets change the world! In this vital role you will provide critical support to the Process Quality function by assisting in the implementation monitoring and continuous improvement of Amgens R&D Quality Management System (QMS) and Regional Quality Oversight.

Accountabilities:

• Assist in maintaining and improving the QMS by helping to track document and implement quality initiatives ensuring that procedures and processes meet regulatory requirements.

• Contribute to the collection analysis and reporting of quality metrics (KPIs KQIs) helping to identify trends risks and areas for continuous improvement.

• Provide hands-on support in ensuring procedural compliance with GCP standards and other regulatory requirements across R&D.

• Act as a liaison between the Process Quality function and Global Networks supporting smooth collaboration and exchange of information.

• Provide quality oversight primarily for key target sites

• Perform focused readiness checks of clinical trials remote and onsite

• Perform risk assessment to support identification of sites for audits

• Identify data quality indicators/trends identify areas of weakness/gaps recommend and implement corrective actions

• Coordinate activities related to site/sponsor inspections and audits - preparation conduct and close out and response generation

Key Capabilities:

• Understanding of SOP/Standards management and methods/technology used to drive knowledge management across a diverse R&D environment

• Communicate effectively

• Develops innovative and creative output based on interpretation and analysis

• In-depth disciplinary knowledge; uses business insight and subject matter expertise

• Employs project management techniques

• Thorough understanding of business priorities strategy and direction

• Integrates trends data and information into plans deliverables and recommendations

• Manages root cause analysis and corrective/prevent action completion follow-up

• Acts as a technical expert in GCP

• Employs critical thinking skills

• Able to separate critical from non-critical issues

• Strong attention to detail and proficiency in managing data and reports.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills and has these qualifications.

Basic Qualifications:

• Doctorate degree OR

• Masters degree and 2 years of Quality/Compliance/Process Management experience OR

• Bachelors degree and 4 years of Quality/Compliance/Process Management experience OR

• Associates degree and 8 years of Quality/Compliance/Process Management experience Or

• High school diploma / GED and 10 years of Quality/Compliance/Process Management experience

Preferred Qualifications:

• 2 years or more experience in Quality Management Quality Assurance or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.

• Solid understanding of SOP/Standards management and methods/ technology used to drive knowledge management across a diverse R&D environment.

• Thorough understanding of Clinical R&D activities and Global Regulations.

• Strong analytical critical thinking and decision-making abilities.

• Strong Process Mind and analytically oriented - experience with process monitoring including applying analytical methods and modern technology to enable signal detection and quality improvement.

• Proven team player takes direction and can rapidly learn and support a hard-working team making rapid decisions and communicating them promptly.

• Excellent verbal and written communication skills - demonstrates strong business writing abilities and active listening.

• Capability to understand and articulate technical concepts and literature in spoken and written English.

What you can expect from 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 well 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.

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.

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.