Job Title: External Manager of Quality AssuranceJob Description As the External Manager of Quality Assurance for Sterile Ophthalmic Products, you will play a pivotal role in ensuring the quality and compliance of our contract manufacturing processes and products. Your primary responsibility will be to lead and manage the Quality Assurance team, implementing and maintaining quality systems that meet regulatory requirements for sterile pharmaceuticals. You will also provide essential administrative assistance to the internal quality department, contributing to the overall efficiency and effectiveness of the team's operations. Responsibilities + Supervise and lead the QA team, providing guidance, training, and support to ensure a high level of performance and compliance. + Foster a culture of continuous improvement, accountability, and proactive problem-solving within the QA team. + Develop, implement, and maintain robust quality systems in collaboration with our Contract Manufacturing Organization (CMO) partners, ensuring compliance with regulatory requirements, including but not limited to cGMP, FDA, and other relevant guidelines. + Conduct joint internal audits with CMOs and oversee external audits to assess compliance with quality standards. + Work closely with our Contract Manufacturing Organization (CMO) partners to stay abreast of changes in regulatory requirements related to sterile ophthalmic products, ensuring joint compliance efforts. + Interface with regulatory agencies during inspections and provide necessary documentation and support. + Collaborate with CMOs to oversee the joint review and approval of batch records, protocols, and documents, ensuring accuracy, completeness, and compliance with established procedures. + Manage and provide approval of deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPA) as needed. + Work collaboratively with CMOs to manage the change control process for sterile ophthalmic products, assessing the impact on quality systems and ensuring joint documentation and approvals. + Collaborate with the procurement team to assess and manage the quality of materials and services provided by external vendors and contract manufacturing organizations (CMOs). + Engage in various quality and compliance projects as delegated by the management. + Fulfill other duties as assigned. Essential Skills + A minimum of BS/BA in a scientific discipline. + 6+ years related industry experience with a minimum of 2 years’ management experience in quality assurance, quality control, and compliance. + Strong organizational skills, including the ability to follow assignments through to completion. + Knowledge of relevant regulations and guidance documents. + Strong decision-making capability and ability to ask compelling questions and to think strategically and understand the global impact of decisions. + Excellent verbal and written communication skills. + Detail-oriented with skills in problem-solving and solid decision-making abilities. + Experience working autonomously with a proven ability to meet deadlines. + Experience with full life cycle project management (initiation, planning and design, and executing). + Experience working with Contract Manufacturing Organizations (CMOs) preferred. + Proficient in the use of standard Microsoft Office software products, including Outlook, Word, and Excel. Additional Skills & Qualifications + Experience with Contract Manufacturing Organizations (CMOs) is preferred. Work Environment We foster individual and collective entrepreneurial and creative spirits. We focus on pursuing opportunities for drug candidates in underserved markets, using data-driven approaches to lower investment risks. Our objective is to make paradigm-shifting medicines available to patients as soon as possible. We offer a comprehensive ophthalmic pharmaceutical portfolio and support mission work aimed at providing the gift of sight to those most in need. Our work environment is one of innovation, patient access, and affordability, with a commitment to never turning down an ophthalmologist doing mission work around the world. Pay and Benefits The pay range for this position is $130000.00 - $150000.00/yr. 5% bonus- will get documents nnovation is at our core. We have worked diligently to create an environment that fosters creativity, challenges the status quo, and turns visions into reality. We believe in the power of collaboration and encourage employees to voice their ideas in every setting. You will be working alongside thought leaders and visionaries who celebrate and value contributions from all facets of the business and encourage every employee to operate with an ownership mindset and adopt our culture of intrinsic motivation. Our most powerful resource is our team, and we are committed to investing in you! Through workshops, training, mentorship programs, and our proprietary educational platform, “Harrow University,” we provide you with the tools you need to elevate your skills and advance your career. Workplace Type This is a hybrid position in Ledgewood,NJ. Application Deadline This position is anticipated to close on Feb 28, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.