This role is responsible for developing a Quality Control unit aligned with ISO 9001 and ISO 17025 standards. It involves building a sustainable departmental structure by evaluating resource needs and implementing training matrices, proficiency assessments, and succession planning to ensure long-term team capability. Testing must be performed according to a defined schedule and executed using written procedures that are either benchmarked or based on industry-validated methodologies. Additionally, the role oversees the evaluation and control of raw materials, work-in-progress (WIP), and finished goods under a positive release system to support business needs.
Key responsibilities Develop, modify, and approve laboratory procedures that define standardized ways of working. Audit current test methods to ensure alignment with industry best practices and compliance with written procedures. Create a training roadmap for both existing staff and new hires. Benchmark laboratory operations against ISO 17025 standards and address any identified gaps. Assess laboratory costs to determine the most effective balance between internal and external testing. Explore alternative testing methodologies to enhance accuracy and efficiency in material evaluation. Manage staffing to support 24/7 laboratory operations. Oversee the timely release of materials in accordance with defined schedules. Lead laboratory investigations as needed. Support plant-level investigations when required. Collaborate cross-functionally to ensure appropriate sampling and testing of raw materials, WIP, and finished products. Implement process capability evaluations by leveraging quality control data and available systems to establish internal process parameters and investigate out-of-trend data. Qualifications and skillsExperience
Minimum of 5 years in a quality control leadership role.Education
BS degree in a science-related field.Key Competencies
Solid working knowledge of GMP, Microbiology, GLP, Hygiene controls, Validation, and HACCP principles. Proficient in IT-based applications such as LIMS and SAP. Ability to assess pharmaceutical ingredient manufacturing for compliance with established regulations. Capable of effectively training plant personnel in excipient principles and ISO standards. Skilled in driving continuous improvement initiatives. Able to influence change through indirect leadership. Experienced in writing SOPs and work instructions. Strong collaboration skills with production and quality teams to build and maintain a robust quality management system. Excellent written and verbal communication skills. Proficient in Microsoft Word, Excel, and PowerPoint. Compensation DataThe typical hiring range for this role is $64,479 to $105,272 annually and is based on several factors including but not limited to education, work experience, certifications, location, etc. In addition to your pay, Kerry offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and retirement contribution (all benefits and incentives are subject to eligibility requirements).
Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov).