Position Title : Director of Quality Control
Location : Maryland
Job Summary :
This role oversees the daily operations of the Quality Control function, ensuring that the team delivers results efficiently and in alignment with strategic goals.
Key Responsibilities :
- Supervise and guide the activities of personnel within the Quality Control Lab.
- Develop and implement long-term strategic plans for both the department and its staff.
- Carry out assignments independently, following guidance from senior management when necessary.
- Oversee and manage laboratory functions, including planning work schedules, setting timelines, and tracking progress.
- Lead, motivate, and develop the QC team, fostering an environment of continuous improvement.
- Collaborate with other departments (e.g., QA, Regulatory, Manufacturing) to execute investigations, respond to deficiencies, and manage CAPA activities.
- Support the development and transfer of formulations for various projects.
- Address method performance and improvement challenges, and evaluate proposed changes to testing methods.
- Prepare and review key documents, including validation protocols, analytical test procedures, and Certificates of Analysis.
- Provide technical training and support to lab staff, standardizing procedures across the team.
- Ensure compliance with cGMP standards, company policies, and regulatory guidelines.
- Maintain and audit laboratory data to ensure accuracy and completeness.
- Recommend new equipment as needed to support evolving operational and regulatory requirements.
- Ensure that all lab equipment is properly qualified, calibrated, and maintained.
- Work closely with cross-functional teams (e.g., R&D, Regulatory, Quality, external vendors) to ensure project objectives are met.
Qualifications :
- Bachelor's degree or an equivalent mix of education, training, and experience.
- 10+ years of experience in analytical chemistry, quality control, or related fields within the pharmaceutical industry.
- Strong knowledge of modern analytical equipment and instrumentation.
- Proven ability to lead investigations, solve problems, and implement corrective actions.
- Experience managing both people and projects, with a demonstrated ability to prioritize and meet deadlines.
- Solid understanding of cGMP regulations and pharmaceutical industry standards.
- Strong leadership, communication, and interpersonal skills, with the ability to work across departments.
- Proficiency in electronic Quality Management Systems and common software tools (e.g., Microsoft Office).
- Ability to analyze complex data, write clear technical reports, and make sound decisions with minimal supervision.
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