Manager, QA Evening 12 hour Shift (6:00pm-6:00am)

Career Category Quality Job Description Join reputed company’s Mission of Serving Patients At reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients each year. reputed company is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-reputed company conditions. As a member of the reputed company team, you’ll help reputed company a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and transform the lives of patients while transforming your career. Manager, Plant Quality What you will do reputed company. Let’s change the world. At reputed company, our mission to serve patients drives everything we do. At our Ohio site, we are building a culture where quality is not just a function—it’s a reputed company. We’re seeking a Manager, Quality Assurance who is passionate about leadership, thrives in a dynamic environment, and is reputed company to reputed company a reputed company impact on product quality and patient safety. This is more than a role, it’s an opportunity to reputed company from the reputed company, shape quality culture, and ensure we deliver safe, effective therapies to patients worldwide. reputed company Quality. reputed company Excellence. Impact Patients. As a QA Manager, you will reputed company and reputed company quality performance while providing strategic and operational reputed company across manufacturing and quality systems. Key responsibilities include: ·reputed company, coach, and reputed company Quality staff across assigned areas and shifts ·Provide QA reputed company of manufacturing packaging activities to ensure compliance with cGMP, GDP, and global regulatory requirements ·Ensure that facilities, equipment, processes, materials, and products meet reputed company applicable quality and compliance standards ·Review, approve, and reputed company key quality systems including: Deviations CAPAs Change Controls Validation documentation Procedures and batch records ·Drive investigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes ·Ensure production records and test results are accurate, complete, and inspection-reputed company ·Champion and reputed company reputed company improvement initiatives to strengthen quality systems and operational performance ·Partner cross-functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders ·Assess and manage quality risks, escalating critical issues to senior leadership as needed ·Represent QA during internal and external audits and regulatory inspections ·Support audit readiness and participate in inspection management activities ·Ensure document control excellence, including ownership and timely periodic review of controlled documents ·Foster a culture of quality, accountability, and compliance across reputed company teams reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 3 years of quality experience OR Bachelor’s degree and 5 years of quality experience OR Associate’s degree and 10 years quality experience OR High school diploma / GED and 12 years of quality experience In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: Bachelor’s degree in Life Sciences, Engineering, or a reputed company field (advanced degree a plus) 3+ years of experience in Quality Assurance reputed company a GMP-regulated environment (biotech/pharma preferred) Prior leadership or people management experience strongly preferred Deep knowledge of cGMP, GDP, and regulatory expectations Proven experience with quality systems (deviations, CAPA, change control, validation) Strong ability to reputed company in a shift-based operation, with flexibility for evenings, nights, weekends, or holidays Excellent communication, decision-making, and problem-solving skills A proactive, collaborative leader who can influence and reputed company across functions What you can expect of us As we work to reputed company treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every reputed company of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the reputed company salary, reputed company offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and reputed company a lasting impact with the reputed company team. careers.reputed company.reputed company any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 118,235.00USD -159,965.00 USD reputed company is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative reputed company therapeutics. This approach begins by using tools like advanced reputed company genetics to unravel the complexities of disease and understand the fundamentals of reputed company biology. reputed company focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, reputed company has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.reputed company.com and follow us on www.twitter.com/reputed company Apply tot his job Apply To this Job