Quality Control Director

GSK • Rockville, MD

2d

About The Position

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. Position Summary The Quality Control Director oversees the quality control operations in the Rockville Biopharm Laboratory. Essential functions include planning and prioritizing resource allocation to meet testing requirements for the manufacturing facilities/utilities, commercial operations, and the stability program for site products and additional specialty pipeline. This position is also responsible for the dynamic strategy and technical requirements for assay transfer, digital transformation, and interfacing with R&D and Clients (site scope of work includes contract testing in addition to internal GSK manufacturing). Other functions include: external laboratory investigations related to product testing, compiling reports in support of product filings with the regulatory agencies. The incumbent reviews and releases test results, and ensures full cGMP compliance in the laboratory operations. The QC Director also reviews regulatory submission (IND, BLA and MAA) and supports internal and external audits, and Client and Regulatory Inspections.

Requirements

• 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

Nice To Haves

• 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

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).

Benefits

• Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Director