Senior QA Manager
Senior QA Manager
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$ 182031 - 182031
1 Vacancy
Job Description
Career Category
OperationsJob 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.
Senior QA Manager
What you will do
Lets do this! Lets change the world!
In this vital role you will lead a team of Quality professionals supporting the Disposition and Incoming Quality operations at our North Carolina site. You will provide technical quality leadership and oversight of Disposition and Incoming Quality partnering closely with cross-functional teams to build enhance and sustain compliant commercial operations.
Specific responsibilities include but are not limited to:
Lead manage and motivate a high-performing team of Quality professionals across key areas including QA support for Disposition and Incoming QA and their applicable quality systems (e.g. Document Management Change Control and Deviations).
Ensure team members are properly trained and qualified to perform their duties in accordance with cGMP and regulatory requirements.
Oversee workload distribution resource planning and departmental budgeting including forecasting and monitoring.
Own the development implementation and continuous improvement of the sites inspection readiness program and overall Quality Management System (QMS) ensuring compliance with Amgen standards cGMP and applicable regulations.
Ensure timely review approval and tracking of key cGMP processes documents and records including deviations CAPAs Change Controls validation protocols and assays.
Lead cross-functional investigations of deviations ensure appropriate documentation and assess changes for potential product quality impact.
Stay current with regulatory developments and quality trends to maintain a compliant and forward-thinking quality program.
Represent the Quality unit during internal and external audits and regulatory inspections.
Alert senior management to significant quality compliance supply or safety risks using sound judgment and cross-functional coordination when needed.
Manage hiring succession planning and performance development to ensure organizational capability and talent pipeline.
What we expect of you
We are all different yet we all use our unique contributions to serve patients! The Manager Quality Control professional we seek is a strong leader with these qualifications.
Basic Qualifications:
High school diploma / GED and 12 years of Quality and Manufacturing support industry experience OR
Associates degree and 10 years of Quality and Manufacturing support industry experience OR
Bachelors degree and 8 years of Quality and Manufacturing support industry experience OR
Masters degree and 6 years of Quality and Manufacturing support industry experience OR
Doctorate degree and 2 years of Quality and Manufacturing support industry experience
Preferred Qualifications:
Educational background in Life Science and/or Engineering
Proven experience in Quality oversight of Incoming Warehouse and Disposition with a strong focus on quality systems.
In-depth knowledge of cGMPs regulatory requirements and pharmaceutical processing with demonstrated ability to apply compliance principles in practice.
Hands-on experience with Disposition Incoming and Quality Systemsparticularly investigations corrective actions and audit readiness.
Experience managing and interacting with regulatory and internal auditors.
Demonstrated leadership of Quality 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 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.
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
149379.00 USD - 182031.00 USDRequired Experience:
Manager
Employment Type
Full-Time
