Overview
Quality Engineer Jobs in Kennesaw, GA at Microcopy
Job Description
General Summary:
The Associate Director of QC Raw Materials manages and directs the Vertex cell and gene therapy raw materials team. This position will provide leadership and technical expertise in Quality Control Raw Materials Program Management. The role is responsible for leading other QC personnel, optimizing Department resource allocation according to project/program needs to assure testing activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values
Key Responsibilities
Develop and execute the QC Raw Materials program strategy for in-house manufacturing of Vertex Cell and Genetic Therapies. This position requires strong partnerships with process development(PD), Supply Chain and Materials Management, Quality Control and Quality Assurance.
Develop and lead a high-performing team, facilitating goal setting and development of direct reports.
Manage relationships with outside stakeholders to ensure QC testing is performed and results are provided to Vertex standards
Manage raw material control program across sites
Support internal and external audits, inspections and technology transfers as required.
Initiate and provide support and guidance for the resolution of investigations, deviations, CAPAs, change controls, and other quality systems issues, as appropriate
Lead training sessions on QC Raw Material owned procedures to QC staff and external groups, as needed.
Support vendor evaluation and associated contracting diligence in conjunction with Supplier Management and Quality Assurance.
Proactively pursue continual improvement and procedural changes
Knowledge and Skills:
Proven track record of building and managing the day-to-day operations of a QC Raw Materials group
Demonstrated knowledge of agency requirements for Raw Materials
Ability to interface effectively with management and other groups, project teams and personnel at manufacturing site
Excellent leadership skills to lead cross functional teams to ensure project success
Excellent interpersonal skills with ability to handle conflict effectively.
Education and Experience:
M.S. or B.S. with a minimum of 10 year’s experience in a cGMP Quality Control lab and 6 years in a managerial role; or equivalent combination of education and experience.
Experience in Raw Materials Quality Control for cell therapy or related products
Experience managing a raw materials control program in clinical and/or commercial setting
Pay Range:
$157,800 – $236,700
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]
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Title: Quality Engineer
Company: Microcopy
Location: Kennesaw, GA
