Sr. Analytical QC Consultant

Sr. Analytical QC Contractor

RESPONSIBILITIES

• Strategically coordinating a team of analysts to perform necessary product, raw material, and environmental testing for company sites and contract manufacturers and laboratories.
• Ensuring that quality control testing processes comply with ICH and GMP regulatory requirements and industry best practices.
• Overseeing the design and implementation of sampling plans for internal sites and contract manufacturers.
• Developing sampling plans to support manufacturing and ensuring efficient and effective testing processes.
• Coordinating the creation, review, and revision of specifications for quality control testing.
• Ensuring internal and external specifications are aligned and meet health authority requirements.
• Creating and maintaining an equipment maintenance program to support required preventative maintenance and calibrations.
• Ensuring all instruments used in quality control testing are calibrated and maintained according to regulatory requirements.
• Ensuring data is generated and stored to maintain integrity within Quality Control.
• Assessing equipment and processes for data integrity compliance.
• Providing expert guidance on data integrity to other parts of the company.
• Establishing strong relationships with key stakeholders, both internal and external.
• Balancing the demands of internal sites with contract suppliers.
• Mentoring emerging leaders by sharing insights and best practices.
• Proactively identifying and resolving conflicts.
• Building partnerships with external organizations to stay at the forefront of industry trends.
• Fostering an environment that values creative thinking and encourages innovation in quality control processes.
• Addressing systemic issues within the business with integrity and determination.
• Making tough decisions with integrity, respect, and empathy for others, taking calculated risks when necessary.
• Demonstrating credibility at the organizational level through visionary leadership and strategic decision-making.
• Taking ownership of actions and decisions while delivering results in line with quality objectives.
• Creating platforms for knowledge exchange and collaboration across departments.
• Driving organizational change initiatives by setting a clear vision and direction.
• Cultivating a culture that embraces change and innovation in quality control processes.

QUALIFICATIONS

• Minimum 10+ years of experience in quality control within the pharmaceutical or biotechnology industry.
• Thorough understanding of regulatory requirements related to quality control testing.
• Strong leadership and interpersonal skills.
• Excellent communication and problem-solving abilities.
• Proven track record of driving change and innovation in quality control processes

EDUCATION

• Bachelor’s or advanced degree in a relevant field (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences).