Laboratory Director – GMP Compliant Analytical Laboratory

Position Summary
:

The
Laboratory Director
will oversee the daily operations, strategic direction, and regulatory compliance of a high-performing GMP Certified analytical laboratory. This role requires extensive knowledge of Health Canada and FDA guidelines to ensure the laboratory's full compliance with all relevant regulatory standards. The Director will lead a multidisciplinary team of scientists and technicians, manage resources efficiently, and ensure high-quality data generation for pharmaceutical products in development, manufacturing, and post-market surveillance.

Key Responsibilities:

Laboratory Operations Management
:

• Oversee all laboratory functions, including sample testing, method development, validation, stability testing, and documentation. Ensure that the laboratory meets timelines and quality expectations while adhering to established protocols.

Regulatory Compliance
:

• Maintain full compliance with FDA, HC, and other relevant regulatory standards. Ensure accurate and timely preparation of regulatory submissions, audits, and documentation, including laboratory investigations, CAPAs (Corrective and Preventive Actions), and SOPs (Standard Operating Procedures).

Quality Assurance
:

• Implement and monitor laboratory quality assurance programs, ensuring that all testing meets FDA and other regulatory requirements. Drive continuous improvement initiatives to enhance testing efficiency and quality.

Team Leadership & Development
:

• Lead and mentor laboratory personnel, fostering a collaborative, results-driven work environment. Provide training and development opportunities for staff in areas such as HC compliance, FDA regulations, and new analytical techniques.

Project Management
:

• Coordinate and prioritize laboratory projects, ensuring the timely and successful completion of all testing requirements. Manage resources, including equipment, supplies, and personnel, to optimize workflow efficiency.

Budgeting & Resource Allocation
:

• Develop and manage the laboratory budget, ensuring efficient use of resources and cost-effective operations. Identify and implement cost-saving measures without compromising quality or regulatory compliance.

Client & Stakeholder Interaction
:

• Serve as the primary point of contact for clients and regulatory agencies regarding laboratory operations, data interpretation, and compliance matters. Communicate results and findings effectively to internal and external stakeholders.

Continuous Improvement
:

• Stay up-to-date with advancements in analytical methodologies, FDA guidelines, and industry best practices. Drive the adoption of new technologies and processes to maintain the laboratory's competitive edge.

Qualifications
:

Education
:

• Ph.D. or Master's degree in Chemistry, Pharmaceutical Sciences, or related field.
• Strong understanding of FDA regulations, cGMP, and ICH guidelines.

Experience
:

• Minimum 10 years of experience in a pharmaceutical analytical laboratory, including at least 5 years in a leadership/management role.
• Proven track record of managing FDA inspections and maintaining FDA compliance.
• Experience with analytical methods such as HPLC, GC, ICP-MS, FTIR, UV-Vis, and dissolution testing.

Skills
:

• Strong knowledge of method development and validation.
• Excellent leadership, communication, and problem-solving skills.
• Experience managing budgets, resources, and teams in a high-pressure environment.
• Familiarity with LIMS (Laboratory Information Management Systems) and other laboratory software.

Certifications
:

• ASQ certification in Quality Management or equivalent is a plus.

Key Competencies
:

• Strong regulatory knowledge and ability to lead laboratory operations in compliance with FDA standards.
• Demonstrated ability to manage complex projects and deliver results on time and within budget.
• Effective leadership in fostering a collaborative team environment and developing high-performing teams.
• Commitment to continuous improvement and staying current with technological and regulatory advancements.