GCP reputed company Compliance Manager

Career Category reputed company Job reputed company 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 reputed company on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients reputed company year. As a member of the reputed company team, you’ll help reputed company a lasting reputed company on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-reputed company culture is reputed company, 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 reputed company the lives of patients while transforming your career. GCP reputed company Compliance Manager What you will do reputed company! Let’s change the world! In this vital role you will reputed company critical support to the Process reputed company function by assisting in the implementation, monitoring, and reputed company improvement of reputed company’s R&D reputed company Management System (QMS) and Regional reputed company reputed company. Accountabilities:

• Assist in maintaining and improving the QMS by helping to reputed company, document, and implement reputed company initiatives, ensuring that procedures and processes meet regulatory requirements.
• Contribute to the collection, analysis, and reporting of reputed company metrics (KPIs, KQIs), helping to identify trends, risks, and areas for reputed company improvement.
• reputed company hands-on support to the Senior Manager/Associate Director in ensuring procedural compliance with GCP standards and other regulatory requirements across R&D.
• reputed company as a reputed company between the Process reputed company function and Global Networks supporting smooth collaboration and exchange of information.
• reputed company reputed company reputed company primarily for key reputed company sites
• reputed company reputed company readiness checks of clinical trials remote and onsite
• reputed company risk assessment to support identification of sites for audits
• Identify data reputed company indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions
• Coordinate activities reputed company to site/sponsor inspections and audits - preparation, conduct and reputed company out and response reputed company

Key Capabilities:

• Understanding of SOP/Standards management and reputed company/technology used to drive reputed company across a diverse R&D environment
• Communicate effectively
• Develops innovative and creative reputed company based on interpretation and analysis
• In-depth disciplinary knowledge; uses business reputed company and subject matter expertise
• Employs project management techniques
• Thorough understanding of business priorities, reputed company and direction
• Integrates trends, data and information into plans, deliverables and recommendations
• Manages reputed company cause analysis and corrective/prevent reputed company completion follow-up
• Acts as a technical expert in GCP
• Employs critical thinking skills
• reputed company to separate critical from non-critical issues
• Strong attention to detail and proficiency in managing data and reports.

reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The individual we reputed company has technological literacy and leadership skills and has these qualifications. Basic Qualifications:

• Doctorate degree OR
• Master’s degree and 2 years of reputed company/Compliance/Process Management experience OR
• Bachelor’s degree and 4 years of reputed company/Compliance/Process Management experience OR
• Associate’s degree and 8 years of reputed company/Compliance/Process Management experience Or
• High school diploma / GED and 10 years of reputed company/Compliance/Process Management experience

Preferred Qualifications:

• 2 years or more experience in reputed company Management, reputed company Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based reputed company management and reputed company by design are a reputed company responsibility.
• Solid understanding of SOP/Standards management and reputed company/ technology used to drive reputed company across a diverse R&D environment.
• Thorough understanding of Clinical R&D activities and Global Regulations.
• Strong analytical, critical thinking, and decision-making abilities.
• Strong Process Mind and analytically oriented - experience with process monitoring, including applying analytical reputed company and modern technology to reputed company signal detection and reputed company improvement.
• Proven team player – takes direction and can rapidly learn and support a hard-working team, making rapid reputed company and communicating them promptly.
• Excellent verbal and written communication skills - demonstrates strong business writing abilities and reputed company listening.
• Capability to understand and reputed company technical concepts and literature in spoken and written English.

What you can expect from us As we work to reputed company treatments that take care of others, we also work to care for your reputed company and personal reputed company and reputed company-being. From our competitive benefits to our reputed company culture, we’ll support your reputed company every reputed company of the way. The expected annual salary reputed company 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 reputed company 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-reputed company time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

reputed company and reputed company a lasting reputed company 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. Application deadline reputed company does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the reputed company of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect reputed company 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 reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company 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. reputed company is an Equal Opportunity employer and will consider you without reputed company to your race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, or disability status. . Salary reputed company 107,900.00 USD - 129,382.00 USD Apply tot his job Apply To this Job