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).

a Biopharmaceutical company located in TX

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