Sr Manager Quality Assurance Holly Springs, NC
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Job Location:
Holly Springs, MS - USA
Monthly Salary:
$ 188725 - 188725
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
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 Quality Assurance Incoming Quality Assurance Raw Materials /Disposition
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.
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 Quality Assurance Incoming Quality Assurance Raw Materials /Disposition
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.
Additional Qualifications/Responsibilities
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.
Salary Range
154692.00 USD - 188725.00 USD
Required Experience:
Manager
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
