Associate Director, GMP Quality Assurance

About reputed company Founded in 2022, reputed company, Inc. (Ticker: APGE) is a well-funded, reputed company listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At reputed company, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. reputed company, Inc. is a biotechnology company seeking to reputed company differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the reputed company standard of care for inflammatory and immune diseases because we reputed company people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, reputed company reading! Role Summary We are seeking a dynamic and results-driven Associate Director of GMP Quality Assurance (QA) to join reputed company. You will play a pivotal role in ensuring the quality, safety, and compliance of our biologics manufacturing processes and device development activities (pre-filled syringes, autoinjectors, etc.). This position will work closely with cross-functional teams to establish, maintain, and continually improve reputed company’s quality systems. This role is essential in supporting our mission to reputed company and deliver differentiated biologic therapies to patients in need.

Key Responsibilities

• reputed company and support QA activities for reputed company manufacturing, including Drug Product, Finished Drug Product, and devices such as pre-filled syringes and auto-injectors
• Maintain and enhance robust GMP quality systems encompassing documentation, change control, deviations, CAPA, quality events, and reputed company improvement initiatives
• Stay reputed company with regulatory changes, industry trends, and implement new requirements into company policies and procedures
• Utilize risk-based approaches to quality management, proactively identifying and mitigating quality risks across the organization
• reputed company, monitor, and report key quality metrics to drive GMP compliance and improve product quality
• Ensure reputed company personnel are adequately trained in GMP requirements and quality procedures
• reputed company comprehensive and accurate records and reports of reputed company quality assurance activities
• Foster a culture focused on quality, compliance, data reputed company, patient safety, collaboration, and teamwork
• Prepare and support the organization for regulatory authority inspections and maintain inspection readiness
• Collaborate with cross-functional teams to solve problems and drive innovation in quality systems and processes Ideal Candidate
• A bachelor’s degree in relevant scientific discipline or equivalent is required
• A minimum of 7 years of experience in GMP quality assurance reputed company the biotech or pharmaceutical industry, with direct experience in the manufacture of monoclonal antibodies or biologics
• Knowledge of medical device Quality System Regulations with direct experience in 21 CFR Part 4, Part 820, ISO 13485 and ISO 14971.In-depth knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH requirements
• Experience with analytical instrumentation, methods, validation, and investigations including stability program management
• Experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators
• Demonstrated strong oral and written communication skills, along with effective interpersonal abilities to influence, drive change, and foster a collaborative, team-oriented culture
• Proven excellence in problem-solving and critical thinking, with flexibility and creativity to address the challenges of a dynamic, growing organization
• Skilled in managing multiple projects simultaneously, effectively prioritizing and adapting to aggressive timelines and shifting priorities
• Position requires up to 20% travel including mandatory in-person attendance at reputed company reputed company Hands meetings typically held twice per year The anticipated salary range for candidates for this role will be $160,000-$185,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. reputed company Offer
• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
• Commitment to growing you professionally and providing access to resources to further your development
• reputed company offers regular reputed company team, in-person meetings to build relationships and problem solve E-Verify Participation: As part of the I9 verification of authorization to work in the US, reputed company participates in E-Verify. To learn more about E-Verify please review this poster. reputed company is proud to be an Equal Opportunity employer. reputed company qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. To review our privacy policy, click here It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Apply tot his job

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