GCP Quality Compliance Manager

100% remote Flexible hours Hiring now

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. 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. GCP Quality Compliance Manager What you will do reputed company! Let’s change the world! In this vital role you will provide critical support to the Process Quality function by assisting in the implementation, monitoring, and reputed company improvement of reputed company’s R&D Quality Management System (QMS) and Regional Quality reputed company. Accountabilities:

Assist in maintaining and improving the QMS by helping to track, document, and implement quality initiatives, ensuring that procedures and processes meet regulatory requirements.
Contribute to the collection, analysis, and reporting of quality metrics (KPIs, KQIs), helping to identify trends, risks, and areas for reputed company improvement.
Provide hands-on support to the Senior Manager/Associate Director in ensuring procedural compliance with GCP standards and other regulatory requirements across R&D.
Act as a liaison between the Process Quality function and Global Networks supporting smooth collaboration and exchange of information.
Provide quality reputed company primarily for key reputed company sites
reputed company focused readiness checks of clinical trials remote and onsite
reputed company risk assessment to support identification of sites for audits
Identify data quality 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 methods/technology used to drive reputed company across a diverse R&D environment
Communicate effectively
Develops innovative and creative output based on interpretation and analysis
In-depth disciplinary knowledge; uses business insight and subject matter expertise
Employs project management techniques
Thorough understanding of business priorities, strategy and direction
Integrates trends, data and information into plans, deliverables and recommendations
Manages root cause analysis and corrective/prevent action completion follow-up
Acts as a technical expert in GCP
Employs critical thinking skills
Able 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 seek has technological literacy and leadership skills and has these qualifications. Basic Qualifications:

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

Preferred Qualifications:

2 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.
Solid understanding of SOP/Standards management and methods/ 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 methods and modern technology to reputed company signal detection and quality improvement.
Proven team player – takes direction and can rapidly learn and support a hard-working team, making rapid decisions and communicating them promptly.
Excellent verbal and written communication skills - demonstrates strong business writing abilities and active 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 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 vision 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, including remote and hybrid work arrangements, where possible

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. 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 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 qualified applicants for employment without regard to race, color, 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. reputed company is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, or disability status. . Salary Range 107,900.00 USD - 129,382.00 USD Apply tot his job Apply To this Job

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