Job summary
Job post source
This job is directly from United Pharma Technologies Inc
Job overview
The Senior Quality Assurance Consultant role at United Pharma Technologies Inc involves providing QA oversight for the Post-Trial Access program and Phase 3 Drug Product provider, ensuring quality and regulatory compliance in clinical and drug product activities.
Responsibilities and impact
The consultant will oversee QA for the PTA program and Phase 3 Drug Product, review study documentation, ensure GCP and GxP compliance, develop SOPs, conduct risk assessments, support QTA development, perform vendor audits, and collaborate with Clinical, Regulatory, and Medical Affairs teams to meet regulatory and sponsor requirements.
Experience and skills
Candidates need 8+ years in Quality Assurance in life sciences or pharmaceuticals, strong GCP and clinical QA background, experience with Expanded Access or Post-Trial Access programs, QTA drafting, vendor audits, knowledge of global regulatory expectations, excellent communication skills, ability to work independently, and preferably prior consulting experience.
Job location and travel
This is a remote position.
Company overview
United Pharma Technologies Inc. is a pharmaceutical and biotechnology company specializing in the development, manufacturing, and distribution of innovative healthcare solutions. The company generates revenue through the production of proprietary drugs, contract manufacturing services, and partnerships with healthcare providers and research institutions. Founded with a mission to address unmet medical needs, United Pharma Technologies has a history of significant contributions to therapeutic advancements, particularly in oncology and rare diseases. Candidates should note its emphasis on cutting-edge research, regulatory compliance, and global market expansion strategies.
How to land this job
Tailor your resume to emphasize your 8+ years of Quality Assurance experience in life sciences, with a strong focus on GCP and clinical QA, especially in Expanded Access or Post-Trial Access programs.
Highlight your expertise in drafting Quality Technical Agreements (QTAs), conducting vendor audits, and managing QA oversight for drug product manufacturing or supply chain processes, aligning with the job's core responsibilities.
Showcase your familiarity with global regulatory requirements such as FDA and EMA standards, and your ability to ensure compliance across cross-functional teams including Clinical, Regulatory, and Medical Affairs.
Apply through multiple platforms including United Pharma Technologies Inc's corporate careers page and LinkedIn to maximize your application exposure and increase your chances of being noticed.
Connect with current employees in the Quality Assurance or Clinical Operations divisions at United Pharma Technologies Inc on LinkedIn. Use ice breakers like commenting on recent company initiatives in post-trial access programs or asking about best practices in QA oversight for Phase 3 drug products.
Optimize your resume for ATS by incorporating keywords from the job description such as 'Quality Assurance,' 'GCP,' 'Post-Trial Access,' 'QTA drafting,' 'vendor audits,' and 'regulatory compliance' to ensure your resume passes automated screenings efficiently.
Leverage Jennie Johnson's Power Apply feature to automate tailored resume submissions, find multiple application portals, and identify LinkedIn contacts to network with, saving you valuable time and boosting your job search effectiveness.
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