Sr. Manager QA
Overview: As a Sr. Manager QA, you will play a pivotal role in overseeing programs that uphold the integrity of our sterile injectable pharmaceuticals. Your expertise will be essential in compounding these medicines, conducting crucial microbiological testing, and ensuring compliance with regulatory standards. This role requires adeptly navigating the legal landscape while prioritizing the production of top-quality products. As a leader within the QA department, you will orchestrate the team’s responsibilities, projects, and overall operations.
– Provide guidance and mentorship to the QA team, fostering their professional growth and development.
– Demonstrate your proficiency in making quality-driven decisions pertaining to all aspects of QA related to Sterility Assurance, spanning manufacturing, facility design, certification, maintenance, investigations, documentation, CAPA (Corrective and Preventive Actions), change control, and regulatory adherence.
– Manage the timely creation and completion of QA documents related to deviations, investigations, CAPAs, change controls, and standard operating procedures (SOPs), accompanied by comprehensive and standardized supporting documentation.
– Oversee the establishment and effectiveness of essential SOPs and training materials, ensuring alignment with company standards.
– Safeguard the consistency of Company quality benchmarks concerning Sterility Assurance across both corporate and site-specific contexts, thereby establishing uniform processes akin to other Company sites.
– Uphold compliance with cGMP guidelines, and applicable state and federal regulations, guaranteeing pharmaceutical integrity.
– Compile and present weekly/monthly reports, incorporating metrics and trend analyses to identify and prioritize avenues for continuous enhancement.
– Spearhead the formulation and implementation of corporate and site policies and procedures pertinent to QA for the Sterility Assurance arena.
– Escalate critical concerns jeopardizing manufacturing, as well as the release of secure and efficacious products that meet rigorous regulatory requisites, to the VP of Quality.
– Enforce pertinent personnel policies and procedures to foster a conducive working environment.
– Execute additional duties as delegated.
Your role will be pivotal in ensuring the safety and efficacy of our pharmaceutical products while adhering to the highest quality standards and regulatory compliance.