Director, Quality Control

Samsung Biologics RKV; Rockville (MD); On-site; USD 140,000 - 210,000; Full time

Job summary

Samsung Biologics is seeking a senior QC leader to guide a cGMP Quality Control laboratory supporting manufacturing and development activities. You will lead a team of lab leaders and analysts, providing technical guidance and ensuring ALCOA data integrity across sampling, testing, and data review.

Responsibilities include ensuring regulatory compliance (FDA/ICH/GMP), coordinating investigations, mentoring staff, and representing QC on cross-functional projects while supporting regulatory

Qualifications

• Bachelor’s degree in a science discipline.
• 10+ years in biopharmaceutical industry with 8+ years in supervision.
• Strong knowledge of GMPs, NIH, ICH guidelines, and FDA regulatory requirements.

Responsibilities

• Lead and empower QC team to ensure data integrity and on-time testing.
• Provide guidance to supervisors and analysts in the Quality Control Laboratory.
• Represent QC on projects and regulatory filings while ensuring compliance.
• Oversee investigations and ensure records and data are well documented.

Skills

Team leadership

GMP compliance

Analytical chemistry

Biopharmaceuticals

Communication skills

Education

Bachelor's degree in science

Job description

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 discipline

Required 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.

Samsung Biologics is a fully integrated CDMO offering state-of-the-art contract development and manufacturing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide.