placements24Easton, MA
Quality Assurance Manager
Quality Assurance Manager
Quality Assurance Manager
placements24Easton, MA
today
Pharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingPharmacy Benefit Management and Other Third Party Administration of Insurance and Pension Funds
Apply for this role →About the Role:
Our client is looking for an experienced and strategic Quality Assurance Manager to lead their QA operations, working remotely. This role is crucial for maintaining the highest standards of quality across all pharmaceutical products and processes, ensuring compliance with national and international regulations. You will be responsible for developing, implementing, and overseeing quality management systems, driving continuous improvement, and fostering a robust quality culture throughout the organization. This is an ideal opportunity for a leader passionate about quality and compliance in the pharmaceutical sector, who excels in a remote work environment.
Key Responsibilities:
Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with GMP and other relevant standards.
Oversee and conduct internal audits and quality reviews to ensure adherence to procedures and regulatory requirements.
Manage external audits by regulatory authorities and customers, ensuring successful outcomes.
Lead and mentor the QA team, fostering a culture of quality awareness and continuous improvement.
Investigate deviations, out-of-specifications (OOS), and customer complaints, implementing corrective and preventive actions (CAPA).
Ensure all pharmaceutical products meet specified quality standards before release to the market.
Requirements:
Master's degree in Pharmacy, Chemistry, or a related scientific discipline.
Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry, with at least 2 years in a managerial role.
Thorough understanding of GMP, ICH guidelines, and regulatory expectations for pharmaceutical quality.
Proven experience in developing and implementing QMS, conducting audits, and managing CAPA systems.
Excellent leadership, communication, and problem-solving skills.
Ability to effectively manage and motivate a remote team.
Benefits:
Highly competitive salary with potential for significant annual bonuses.
Comprehensive benefits package including health, dental, and vision insurance.
Generous remote work allowance and home office support.
Retirement fund with matching contributions.
Opportunities for leadership development and to shape the quality strategy of a growing company.
Also on the board Same function, level within a rung
Level
Manager
Location
Easton, MA
Occupation
Quality Control Systems Managers
Industry
Pharmaceutical Preparation Manufacturing
Posted
today