Quality Control Manager

Quality Control Manager




This position will be responsible for operational oversight of the Quality Control group and ensures that all analytical testing complies with company standards and meet all applicable regulatory requirements.

The QC Manager should provide direction and training for QC employees; ensure collaborative and effective working relationships with the manufacturing, quality, and regulatory groups.  This role assures strategic alignment to site vision, strategic, and operational plans to assure achievement of site and business objectives.  This position has responsibility for the design, implementation and continuous improvement of the site Laboratory System in compliance with Huvepharma corporate policies and standards, FDA’s current GMP standards, any other applicable national and international laws, standards and regulatory requirements.  Additionally, the role has responsibility to apply scientific fundamentals and problem-solving skills to solve complex technical issues.


  • Bachelor’s Degree in Biology, Chemistry or related field of study required; Masters or Ph.D. preferred
  • 5 – 10 years of experience in an FDA regulated pharmaceutical facility
  • Extensive experience in a pharmaceutical QC environment


  • Diverse and demonstrated technical knowledge with extensive experience in analytical method development and validation
  • Experience with various regulatory agencies, audits, etc.; as well as experience with regulatory requirements, such as FDA guidance and ICH guidelines.
  • Proficiency in Excel, Word, PowerPoint, and Adobe Acrobat
  • Leadership ability and excellent oral and written communication skills.
  • Critical thinker and problem solver, able to think strategically and act tactically.
  • Excellent technical writing skills.
  • Excellent supervision and leadership skills.
  • Strong Analytical skills and technical competency required in QC test method development and validation, troubleshooting test methods, developing plans to address lab issues and conducting investigations.
  • Ability to train and manage people.
  • In-depth knowledge of GMP requirements for a pharmaceutical QC Lab.
  • Hands on approach.
  • QC documentation preparation and review with a strong understanding of GMP document requirements.
  • Must be a seasoned QC manager that can be self-sufficient and able to execute without close supervision.
  • Experience with project planning and project management.
  • Strong interpersonal communications and ability to develop a team approach.
  • Able to function effectively in a multi-discipline / multi-tasking environment / changing situation.
  • Proactive and engaging. Able to develop and nurture close collaborative relationships across functional boundaries.
  • Flexibility to deal with varying cultures and executive management styles.


  • Manage the development of new test methods, troubleshoot existing methods, and validate test methods.
  • Strategize and execute plans to address regulatory compliance requirements such as FDA incomplete letters, new product introductions, and remediating QC quality systems to assure compliance with FDA cGMP and other quality standards.
  • Assure compliance with applicable FDA cGMPs – 21 CFR 210/211, 21 CFR 225, and 21 CFR 226.
  • Assure compliance with corporate quality and site quality policies, standards, and programs.
  • Assure compliance with Data Integrity requirements.
  • Manage regulatory compliance related projects, and compliance enhancement plans.
  • Prepare technical reports, presentations, and documents to support regulatory submissions.
  • Manage routine laboratory operations, including stability program and feeds program.
  • Lead the continuous improvement program related to process optimization within the laboratory; identifying efficiencies for existing QC processes.
  • Assure all SOPs meet all applicable regulatory and company requirements and are kept current.
  • Develop, review, approve and drive implementation of laboratory systems.
  • Manage investigations utilizing a scientific approach and identify appropriate corrective actions.
  • Provide updates and required communications to senior leadership levels.
  • Represent QC as Subject Matter Expert during Regulatory Inspections and other audits.
  • Lead and participate in FDA remediation efforts associated with QC Lab systems.
  • Advise company management of new innovations in quality control and improvements for laboratory operations.
  • Maintain relationships with appropriate associates and other information sources for personal knowledge and growth in areas of responsibility.
  • Direct and manage all reports for adherence with job descriptions, company programs and policy.
  • Analyze all report positions for adequacy of job function and any needed changes.
  • Independently develop project plans to achieve desired results with minimal oversight.
  • Support Director of Quality through budget planning process and ensure adherence to approved QC budget.
  • Identify CapEx projects to improve existing QC processes and equipment.
  • Other job responsibilities as deemed necessary by the Director of Quality.

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