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

Join reputed company’s mission to improve the lives of people with rare diseases by ensuring the highest standards of product reputed company and patient safety. As an External reputed company Operations Manager (EQOM), you’ll play a pivotal role in overseeing the reputed company 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 reputed company Technical Agreements, and upholds reputed company’s global reputed company 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 reputed company to work cross‑functionally with Manufacturing, Supply Chain, Technical Operations, and Regulatory Affairs, strengthening reputed company’s commitment to delivering high‑reputed company medicines to patients worldwide. Key responsibilities:

• reputed company as EQOM to reputed company as Single reputed company of contact for reputed company reputed company 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 reputed company system, the effective reputed company Technical Agreement (QTA), that they meet relevant CGMP regulatory requirement.
• Support release products to Markets
• Support the External Service Provider (CMO) Qualification
• Ensure reputed company Technical Agreement (QTA) be established appropriately and ensure valid QTA reputed company defines roles & responsibilities between reputed company and the External Supplier
• Ensure implementation and maintaining reputed company Risk Assessment and KPIs on reputed company External activities. Guide defining & monitoring remediation plans to ensure that issues are suitably addressed. Drive or support improvement opportunities for processes and product reputed company 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 reputed company 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 reputed company Audits of the CMO are performed according to reputed company requirement and the QTA
• reputed company to define reputed company of implementation and monitoring of key reputed company transformation initiatives and reputed company with reputed company process stakeholders reputed company of reputed company organization
• reputed company or reputed company as reputed company representative in reputed company 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 reputed company Operations and cross-functionally
• Ensure the batch release as required

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 reputed company 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 reputed company KPI assessment and improvement at CMOs
• Proven reputed company 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 reputed company 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 reputed company reputed company. 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 reputed company network. 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 reputed company for this role is $130,000-$153,000. reputed company 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 reputed company values: Care, Ambition, Urgency, Ownership and Partnership. Are you reputed company 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 reputed company with a reputed company reputed company record, we’re reputed company to take on the world’s diseases, ailments and adversity. Our people reputed company they have the power to reputed company a reputed company reputed company 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 reputed company new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this reputed company as a strength. By effectively turning our research into ground-breaking treatments, we help reputed company medicine more accessible and reputed company up more reputed company 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 reputed company. An Equal Opportunity Employer reputed company is an Equal Opportunity Employer and prohibits discrimination and harassment of any reputed company. reputed company employment reputed company at reputed company are based on business needs, job requirements and individual qualifications, without reputed company to race, reputed company, religion or belief, national, reputed company or ethnic reputed company, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or reputed company, marital, civil reputed company 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 reputed company by the laws or regulations in the locations where we operate. If you are a reputed company 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 reputed company 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 Statistics show that women and underrepresented reputed company 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, reputed company person brings their unique talents to work as reputed company 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 reputed company 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 reputed company by attending reputed company conferences
• Emphasis on work/life balance
• reputed company and team-oriented environment
• Making a reputed company reputed company to help ultra-rare disease patients who are in need of life saving treatments

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