Director, Quality Control

Samsung BioLogics Co.; Rockville, Northern (MD, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Samsung BioLogics Co. in Rockville, MD seeks a Director of Quality Control to lead a cGMP QC lab. You will mentor leaders, guide analysts, and ensure data integrity in sampling, testing, and data review in line with ALCOA principles.

You will assure regulatory compliance (GMP, NIH, ICH, FDA) and drive timely investigations and investigations closure, while supporting IND/BLA/MAA filings and internal projects.

Qualifications

• Bachelor’s degree in a science discipline.
• 10+ years of industrial biopharmaceutical experience.
• 8+ years of supervisory/managerial experience.
• Experience with GMP, NIH, ICH, FDA regulatory requirements for analytical/ stability operations.
• Strong communication and cross-functional leadership.

Responsibilities

• Lead and empower QC laboratory leaders to ensure data integrity per ALCOA.
• Provide technical guidance to analysts and supervisors in QC Laboratory and Operations.
• Ensure compliance with GMP, NIH, ICH, FDA regulatory requirements for validation and operations.
• Support regulatory submissions (IND, BLA, MAA) as needed.
• Oversee sample management, environmental monitoring, and release testing for components, intermediates, APIs, and finished products.
• Represent QC on projects and committees within Samsung.

Skills

Leadership

Regulatory compliance

GMP knowledge

Analytical chemistry

Microbiology

Education

Bachelor's degree in a science discipline

Job description

## Director, Quality ControlApply: Rockville: Full time: Posted 30+ Days Ago: R17* 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 Samsung.* 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).**Educations**- Bachelor’s degree in a science disciplineRequired Experiences* 10+ years industrial experience in biopharmaceutical industry, such as Biochemistry, Analytical Chemistry, Microbiology or related field, particularly in the area of assessing physiochemical characteristics of product purity, activity and functional indicators of biological products, along with 8+ years of supervisory and managerial experiences is desired**Knowledge*** Demonstrated success leading a team comprised of varying levels of technical expertise and functions.* Strong verbal and written communication skills.* Able to interact with peers, subordinate and senior personnel in multidisciplinary environment.* 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