Senior Manager, Commercial Product Quality (TLX250-CDx and TLX101-CDx)

Senior Manager, Commercial Product Quality (TLX250-CDx and TLX101-CDx)

About the role

Responsible for driving commercial product quality initiatives for TLX250-CDx and TLX101-CDx in the US market. Oversee quality assurance processes, ensure compliance with regulatory standards, and collaborate with cross-functional teams to improve product quality and customer satisfaction.

Responsibilities

• Develop and implement quality assurance strategies for TLX250-CDx and TLX101-CDx products
• Oversee quality control processes to ensure compliance with FDA and other regulatory requirements
• Collaborate with sales and marketing teams to align product quality goals with business objectives
• Conduct regular quality audits and provide feedback to improve product quality
• Work closely with regulatory affairs team to manage product approvals and registrations

Requirements

• Bachelor's degree in a related field (e.g., chemistry, biology, engineering)
• Minimum 8 years of experience in pharmaceuticals or biotechnology industry, with at least 5 years in a leadership role
• Proven track record of successfully managing quality assurance programs
• Strong understanding of FDA regulations and guidelines
• Excellent communication and collaboration skills
• Ability to work independently and manage multiple projects simultaneously

Qualifications

• Experience with quality management systems (e.g., ISO 9001)
• Knowledge of statistical process control (SPC)
• Experience with regulatory submissions and approvals

Skills

• Strong analytical and problem-solving skills
• Effective communication and interpersonal skills
• Proficient in Microsoft Office Suite
• Ability to work in a fast-paced, dynamic environment

Benefits

• Competitive salary package
• Flexible remote work options
• Professional development opportunities
• Health insurance benefits
• Employee discounts on company products

Pay

Commensurate with experience and qualifications

Schedule

Full-time