PQM contractor

We are seeking a highly motivated Quality Assurance Specialist to join our team. As an individual contributor, you will play a crucial role in ensuring that all of our company's products, managed by EQA (External Quality Assurance), are manufactured, packaged, tested, released, stored, and distributed in full compliance with company standards and applicable regulatory requirements. You may also be responsible for overseeing the quality aspects of manufacturing activities at our External Entity (EE) sites. This includes ensuring compliance with approved processes, methods, and regulatory filings.Primary Activities:Ensure compliance with established policies, procedures, and governmental regulations (both domestic and foreign), including Good Manufacturing Practices (GMP) and other relevant quality standards.Maintain expertise in EQA systems, tools, data, and processes, providing ongoing support and guidance.Drive the development and coordination of change controls to facilitate the transition of our company as an independent company.Collaborate with stakeholders within EQA, External Manufacturing, and other relevant networks to support change control activities and the successful exit from the Transition Service Agreement with MSD.Operate in accordance with safety policies and guidelines to maintain a safe and efficient work environment.Skills Required:Education: Minimum of a four-year degree in Science, Engineering, or a related technical discipline (e.g., BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).Minimum five years of relevant experience in the pharmaceutical or biotechnology industry, with a strong understanding of Quality Systems, Quality Assurance, and Quality Control, including a comprehensive knowledge of global GMP and regulatory requirements.Excellent interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to foster strong relationships.Ability to collaborate across organizational boundaries and demonstrate effective interpersonal, relationship-building, and leadership abilities.Proficient in verbal and written communication in English.Preferred Experience and Skills:Experience in overseeing and managing external partners.Knowledge and experience in change control management.Familiarity with domestic and foreign GMP regulations and compendia governing plant operations.

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