What are the responsibilities and job description for the Director, Quality Assurance - Holly Springs, NC position at VetJobs?
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, 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.
DIRECTOR, QUALITY ASSURANCE
What you will do
Let’s do this. Let’s change the world. In this vital role you will be accountable for leading the quality team supporting drug substance manufacturing execution activities within our site’s second FleX Batch manufacturing facility.
As a QA Director, you will build and lead a high-performing quality organization responsible for supporting 24/7 manufacturing operations and will contribute to the development of the site Quality strategy leading teams accountable for all aspects of quality oversight of GMP systems and operations, while fostering a culture of execution excellence, accountability, and continuous improvement.
Provide Quality input and expertise to support project and operational design decisions.
Lead operational readiness activities to implement quality systems, programs, business processes and procedures. Track progress and communicate status.
Lead and participate in Quality Risk Assessments.
Build organization according to hiring strategy that supports project milestones.
Recruit, coach, develop, motivate, and retain staff.
Ensure ongoing organizational structure capable of adapting to evolving business needs.
Drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies.
Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties.
Represent ANC Quality in cross-function and cross-site forums and in collaborations with Quality leaders across the Amgen network.
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.
Auto req ID
474091BR
Minimum Education Required
High School/GED
Job_Category
Engineering
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.
Basic Qualifications
Bachelor’s degree and 10 years of Quality/Manufacturing/Engineering experience OR
Master’s degree and 8 years of Quality/Manufacturing/Engineering experience OR
Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience
In addition to meeting at least one of the above requirements, you must have at least 4 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
Bachelor’s Degree in a Science field
15 years of experience in Quality within the biopharmaceutical or regulated manufacturing industry
Previous experience in Quality oversight of Biologics drug substance operations
Strong knowledge of cGMPs and experience interacting with Regulators
Able to drive process improvement within area of responsibility
Able to successfully manage workload to timelines
Proven experience supporting regulatory inspections and site audits
Demonstrated leadership of cross-functional teams within a manufacturing site
Experience driving operational excellence and continuous improvement initiatives
Excellent communication, leadership, and influencing skills
Competencies
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.
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.
Salary Range
181,620.35USD -245,721.65 USD
City*
Holly Springs
State*
North Carolina
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
$75,000-$100,000
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, 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.
DIRECTOR, QUALITY ASSURANCE
What you will do
Let’s do this. Let’s change the world. In this vital role you will be accountable for leading the quality team supporting drug substance manufacturing execution activities within our site’s second FleX Batch manufacturing facility.
As a QA Director, you will build and lead a high-performing quality organization responsible for supporting 24/7 manufacturing operations and will contribute to the development of the site Quality strategy leading teams accountable for all aspects of quality oversight of GMP systems and operations, while fostering a culture of execution excellence, accountability, and continuous improvement.
Provide Quality input and expertise to support project and operational design decisions.
Lead operational readiness activities to implement quality systems, programs, business processes and procedures. Track progress and communicate status.
Lead and participate in Quality Risk Assessments.
Build organization according to hiring strategy that supports project milestones.
Recruit, coach, develop, motivate, and retain staff.
Ensure ongoing organizational structure capable of adapting to evolving business needs.
Drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies.
Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties.
Represent ANC Quality in cross-function and cross-site forums and in collaborations with Quality leaders across the Amgen network.
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.
Auto req ID
474091BR
Minimum Education Required
High School/GED
Job_Category
Engineering
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.
Basic Qualifications
Bachelor’s degree and 10 years of Quality/Manufacturing/Engineering experience OR
Master’s degree and 8 years of Quality/Manufacturing/Engineering experience OR
Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience
In addition to meeting at least one of the above requirements, you must have at least 4 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
Bachelor’s Degree in a Science field
15 years of experience in Quality within the biopharmaceutical or regulated manufacturing industry
Previous experience in Quality oversight of Biologics drug substance operations
Strong knowledge of cGMPs and experience interacting with Regulators
Able to drive process improvement within area of responsibility
Able to successfully manage workload to timelines
Proven experience supporting regulatory inspections and site audits
Demonstrated leadership of cross-functional teams within a manufacturing site
Experience driving operational excellence and continuous improvement initiatives
Excellent communication, leadership, and influencing skills
Competencies
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.
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.
Salary Range
181,620.35USD -245,721.65 USD
City*
Holly Springs
State*
North Carolina
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
$75,000-$100,000
Salary : $75,000 - $100,000