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Quality Control Director jobs in United States
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GSK · 15 hours ago

Quality Control Director

GSK is a global biopharma company dedicated to uniting science, technology, and talent to improve health outcomes. The Quality Control Director will oversee quality control operations, ensuring compliance with regulations and managing resources for testing requirements in the Rockville Biopharm Laboratory.
BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Ensures a cGMP laboratory to meet the work demand in support of manufacturing and development work as needed
Provides in depth technical and scientific advice and guidance to laboratory supervisors and analysts in the Quality Control Laboratory and Operations
Leads and empowers a team of lab leaders to ensure the laboratory is a data factory with analysts and systems that support the sampling, testing, and generation and review of data per ALCOA principles
Ensures that departmental laboratory and manufacturing related investigations are completed in a timely manner
Ensures that the Quality Control team continues to grow technically and professionally; encourages their development efforts toward excellence and a higher degree of proficiency
Provides leadership by ensuring compliance of the department with laws, regulations, guidelines, procedures, and practices governing analytical Quality Control testing, including the departmental, and company Standard Operating Procedures, and safety procedures
Ensures that processes are in place to ensure that records and technical data are accurately maintained and results well documented
Represents the Quality Control department and departmental functions on projects/committees within GSK
Provide support of product filings with regulatory agencies (IND, BLA MAA etc)
Analytical and microbiological testing and release of all components, raw materials, excipients, intermediates, active pharmaceutical ingredients (APIs), finished product and stability samples, if applicable
Sample management, including retain and stability samples as required
Environmental and utilities monitoring (microbiological assurance and process control)

Qualification

CGMP complianceBiopharmaceutical industry experienceAnalytical chemistryMicrobiologyRegulatory submissionsGMP guidelinesTeam leadershipCommunication skillsProblem-solving

Required

Bachelor's degree in a life science, chemistry, engineering or related discipline
10+ years industrial experience in biopharmaceutical industry, such as Biochemistry, Analytical Chemistry, Microbiology or related field
8+ years of supervisory and managerial experiences

Preferred

Demonstrated success leading a team comprised of varying levels of technical expertise and functions
Demonstrated success developing teams
Strong verbal and written communication skills
Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including development, engineering, facility operations, validation, production and QA
Able to prioritise and decide appropriate course of actions. Effective at implementing decision
Fully versed in GMP's, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of analytical and stability functions

Benefits

Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave

Company

We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia

H1B Sponsorship

GSK has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)

Funding

Current Stage
Public Company
Total Funding
$25.51M
Key Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO

Leadership Team

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Luke Miels
Chief Executive Officer
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Julie Brown
CFO
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Company data provided by crunchbase