Quality Control Director

GSK

About The Position

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).