Job Description:
Essential Responsibilities
- Enforce quality standards, maintaining regulatory compliance.
- Schedule and monitor daily department operations based on client demands.
- Conduct facility walkthroughs to ensure regulatory adherence.
- Approve investigations and documentation of non-conformities and out-of-spec results.
- Identify and implement process improvements to enhance departmental efficiency.
- Maintain audit readiness through staff training, documentation review, and lab upkeep.
- Interact with internal and external clients, resolving queries and concerns.
- Manage and lead projects, optimizing resource use and meeting project targets.
- Develop and supervise staff, ensuring clear communication, performance feedback, and corrective action when necessary.
Competencies
- Effective decision-making and problem-solving.
- Relationship-building with collaborative and influencing skills.
- Strong verbal and written communication, confidentiality, and feedback skills.
- Continuous improvement mindset, fostering innovation and efficiency.
- Supervisory and performance management abilities.
Qualifications
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Education: Bachelor's degree in Science or relevant field.
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Experience: Minimum 5-7+ years in an analytical lab or biopharmaceutical industry; cGMP and quality systems experience.
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Skills: Proficient in MS Office, LIMS, and knowledgeable of FDA/EU regulatory standards.