Head of Quality Control

Fraser Dove International; Maryland; On-site; USD 180,000 - 240,000; Full time

Job summary

Fraser Dove International is partnering with an established biopharmaceutical organisation in Maryland to direct Quality Control laboratory operations. The Director will lead laboratory leaders and analysts, ensure compliant sampling, testing, data integrity and release activities in alignment with ALCOA and regulatory requirements.

You will drive scientific excellence, oversee investigations, support IND/BLA/MAA submissions, and develop the QC team and processes.

Qualifications

• 10+ years of biopharma experience in analytical/biochemistry or microbiology.
• 8+ years of supervisory/managerial experience across technical teams.
• Strong written and verbal communication with cross-functional partners.
• Bachelor's degree in a science.
• Extensive GMP, NIH, ICH, FDA regulatory knowledge.

Responsibilities

• Lead and empower laboratory leaders and analysts to support compliant sampling, testing, data generation and review.
• Provide in-depth technical guidance to laboratory supervisors, analysts and Operations.
• Ensure investigations are completed timely with accurate records and documented data.
• Develop the QC team technically and professionally, raising proficiency and scientific excellence.
• Ensure compliance with SOPs and safety procedures governing analytical QC testing.
• Support regulatory filings (IND, BLA, MAA) submissions.
• Oversee testing and release activities, sample management, stability and monitoring.

Skills

Leadership

Regulatory knowledge

Quality systems

ALCOA / data integrity

Communication

Project management

Education

Bachelor's degree in a science

Job description

Do you want to lead Quality Control operations within a regulated biopharmaceutical manufacturing environment?

Are you ready to develop laboratory leaders while driving scientific excellence, compliance and reliable testing?

Do you have the technical and regulatory expertise to strengthen laboratory performance and support the manufacture of high-quality biological products?

Fraser Dove International is partnering exclusively with an established biopharmaceutical organisation. Operating in Maryland, they are committed to delivering compliant laboratory operations that support the manufacture and development of high-quality biological products.

Our client is seeking an experienced leader to direct Quality Control laboratory operations, develop technical teams and ensure compliant analytical and microbiological testing.

Discover more about our Director, Quality Control opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.

Your objectives:

• Maintain a compliant current Good Manufacturing Practice (cGMP) Quality Control laboratory that meets manufacturing and development testing demands while protecting data integrity.
• Ensure timely, accurate and compliant testing, release, investigations and monitoring activities across Quality Control operations.
• Build a high-performing Quality Control organisation by developing laboratory leaders and technical teams while strengthening scientific capability and regulatory compliance.

What you will do:

As the Director, Quality Control, your duties and responsibilities will include:

• Lead and empower laboratory leaders and analysts to support compliant sampling, testing, data generation and review in line with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) principles.
• Provide in-depth technical and scientific guidance to laboratory supervisors, analysts and Operations.
• Ensure laboratory and manufacturing-related investigations are completed in a timely manner, with accurate records and well-documented technical data.
• Develop the Quality Control team technically and professionally, encouraging greater proficiency and scientific excellence.
• Ensure departmental compliance with applicable laws, regulations, guidelines, Standard Operating Procedures (SOPs) and safety procedures governing analytical Quality Control testing.
• Support product filings with regulatory agencies, including Investigational New Drug (IND), Biologics Licence Application (BLA) and Marketing Authorisation Application (MAA) submissions.
• Oversee analytical and microbiological testing and release activities, sample management, stability and retain samples, and environmental and utilities monitoring, as applicable.

What you will bring:

• 10+ years of industrial experience within the biopharmaceutical industry, including biochemistry, analytical chemistry, microbiology or a related field.
• Experience assessing the physicochemical characteristics, purity, activity and functional indicators of biological products.
• 8+ years of supervisory and managerial experience is desired, with demonstrated success leading teams across different levels of technical expertise and functions.
• Strong verbal and written communication skills, with the ability to work effectively with peers, direct reports and senior personnel in a multidisciplinary environment.
• Strong prioritisation and decision-making skills, with the ability to select and implement an appropriate course of action.
• A bachelor's degree in a science discipline.
• Extensive knowledge of Good Manufacturing Practice (GMP), National Institutes of Health (NIH), International Council for Harmonisation (ICH) guidelines, US Food and Drug Administration (FDA) requirements and other regulatory agency requirements for analytical and stability operations.

Got what it takes?

Please Note:

• This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be