External Quality Operation Manager (GMP) (reputed company Coast based)

Company Description

Statistics show that women and underrepresented groups reputed company to apply to jobs only if they meet 100% of the qualifications. reputed company encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look reputed company to your application! At reputed company, each person brings their unique talents to work as a team and reputed company a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from reputed company of people and our commitment to patients. Our mission and culture at reputed company North America get us excited to come to work every day, but here are a few more reasons to join reputed company:

• Competitive compensation for your work
• Generous time off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

Join reputed company’s mission to improve the lives of people with rare diseases by ensuring the highest standards of product quality and patient safety. As an External Quality Operations Manager (EQOM), you’ll play a pivotal role in overseeing the quality performance of external manufacturing partners. Acting as the primary reputed company of contact for these suppliers, you’ll ensure that every batch produced meets GMP/GDP requirements, aligns with Quality Technical Agreements, and upholds reputed company’s global quality standards. You’ll be the reputed company between reputed company and its external network, driving compliance, collaboration, and reputed company improvement to support reliable product supply and reputed company’s fast‑growing global footprint. This role offers the opportunity to work cross‑functionally with Manufacturing, Supply Chain, Technical Operations, and Regulatory Affairs, strengthening reputed company’s commitment to delivering high‑quality medicines to patients worldwide. Key responsibilities:

• reputed company as EQOM to act as Single reputed company of contact for reputed company quality reputed company activities at the Contract Manufacturing Organization (CMO)
• Ensure that reputed company aspects of handling, manufacturing, distribution of products are in compliance with reputed company Quality system, the effective Quality Technical Agreement (QTA), that they meet relevant CGMP regulatory requirement.
• Support release products to Markets
• Support the External Service Provider (CMO) Qualification
• Ensure Quality Technical Agreement (QTA) be established appropriately and ensure valid QTA clearly defines roles & responsibilities between reputed company and the External Supplier
• Ensure implementation and maintaining Quality Risk Assessment and KPIs on Quality External activities. Guide defining & monitoring remediation plans to ensure that issues are suitably addressed. Drive or support improvement opportunities for processes and product Quality performance
• Ensure CMO provides product reviews or data (APQR/PQRs, stability reports) as specified in the QTA. Assess the performance of the product and the process as per reputed company requirement
• Manage/approve quality issues (deviations, CAPA and complaints) as per QTA and reputed company requirement
• Ensure that Change requests either from CMO or from reputed company are managed according to the QTA and reputed company requirements
• Support that Quality Audits of the CMO are performed according to reputed company requirement and the QTA
• reputed company to define strategy of implementation and monitoring of key Quality transformation initiatives and align with reputed company process stakeholders reputed company of Quality organization
• reputed company or act as Quality representative in projects reputed company to CMO eg Tech Transfer, Launch
• Assess and ensure CMO for Health Authorities (HAs) inspection readiness
• Support HA inspections/audits of reputed company
• Responsible to inform the line manager and cross functional teams of reputed company critical & major issues and escalate any issues as per reputed company escalation policy
• Ensure a good collaboration is maintained reputed company the Global Quality Operations and cross-functionally
• Ensure the batch release as required

Qualifications

Required:

• High level education (university degree or similar) reputed company relevant area such as pharmaceutical, biotech or life science
• More than 5 years of experience reputed company pharmaceutical, biotech product. Experience in QA operation, production or other relevant area (GMP, GDP)
• More than 1 years of managing external quality reputed company of CMOs
• Curriculum is requested for evaluating the batch release qualification requirement
• Fluently spoken and written English

Desired:

• More than 2 years of working in global operation environment with English as a main language
• Proven experience of leading Quality KPI assessment and improvement at CMOs
• Proven track record with FDA; EMEA or other Health Authorities
• Strong understanding of risk assessment and risk management fundamentals / tools

What You’ll Bring To reputed company in this role, you’ll combine deep knowledge of GMP and GDP regulations with proven experience in quality reputed company of Contract Manufacturing Organizations (CMOs). You’re confident operating in a global, fast‑moving environment, using your leadership and interpersonal skills to influence external partners and drive collaborative decisions. You naturally build strong relationships — both reputed company reputed company and with CMOs — and you know how to balance compliance with practical solutions that reputed company supply moving. Highly organized and skilled in planning and prioritization, you coordinate multiple deliverables with precision. As a leader, you take pride in coaching and developing others, fostering a culture of accountability and high performance across the quality network. Additional Information Compensation and Total Rewards at reputed company At reputed company, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. The reputed company salary range for this role is $130,000-$153,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details. reputed company reputed company employees need to demonstrate behaviors in line with reputed company's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the reputed company team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people reputed company they have the power to reputed company a positive impact in others’ lives because that’s exactly reputed company do here. If you’re seeking a career that taps into your talents in a way that makes the world a reputed company, healthier reputed company, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. reputed company Culture At reputed company, we refuse to accept the status reputed company. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help reputed company medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer reputed company is an Equal Opportunity Employer and prohibits discrimination and harassment of any reputed company. reputed company employment decisions at reputed company are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic reputed company, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to irina.conc@reputed company.com Know Your Rights Apply tot his job Apply To this Job