Senior Manager Quality Assurance Incoming Quality and Warehouse

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity and obesity-related conditions. 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.

Senior Manager QA

What you will do
Lets do this. Lets change the world. At Amgen our mission to serve patients drives everything we do. At our Ohio site we are building a culture where quality is not just a functionits a mindset. Were seeking a Senior Manager Quality Assurance who is passionate about leadership thrives in a dynamic environment and is ready to make a tangible impact on product quality and patient safety. This is more than a role its an opportunity to lead from the front shape quality culture and ensure we deliver safe effective therapies to patients worldwide.

Responsibilities:

• Lead coach and develop the QA team responsible for quality oversight of Incoming Quality Warehouse Operations Distribution and Facility and Engineering. Team scope includes disposition of product materials and components including on-the-floor support record review quality oversight of deviation investigations and changes document approval.

• Ensure AOH product is manufactured tested stored and distributed according to current Good Manufacturing Practices (cGMP) Amgen standards and applicable regulations.

• Drive investigations and resolution of deviations ensuring timely thorough and compliant outcomes.

• Lead and participate in Quality Risk Assessments.

• Provide Quality input to support project or operational design decisions.

• Build organization according to hiring strategy that supports our growth. Partner with HR to recruit coach develop motivate and retain staff. Ensure ongoing organizational structure capable of adapting to evolving business needs.

• Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards.

• Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies.

• Develop strategies in support of regulatory inspections and site audits.

• Serve as quality representative to regulatory authorities Amgen Corporate auditors and 3rd Parties.

• Develop area budget manage expenditure and identify productivity improvement opportunities.

• Represent AOH Quality in cross-function and cross-site forums.

• Alert management of significant quality compliance supply and safety risks.

• Communicate across all levels of the organization. Facilitate development of solutions to critical business issues.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The quality professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Quality/Manufacturing/Engineering experience

Or

Masters degree and 6 years of Quality/Manufacturing/Engineering experience

Or

Bachelors degree and 8 years of Quality/Manufacturing/Engineering experience

Or

Associates degree and 10 years of Quality/Manufacturing/Engineering experience

Or

High school diploma / GED and 12 years of quality/Manufacturing/Engineering experience

In addition to meeting at least one of the above requirements you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• Master or Bachelors Degree in a Life Science field

• 5 years pharmaceutical industry experience

• Previous experience in Quality oversight

• Strong knowledge of cGMPs and experience interacting with Regulators

• Proven experience with quality systems (deviations CAPA change control validation)

• Able to drive process improvement within area of responsibility

• Able to successfully manage workload to timelines decision-making and problem-solving skills

• Leadership and communication skills. A proactive collaborative leader who can influence and inspire across functions.

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 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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.

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.