reputed company Systems Manager
POSITION TITLE
reputed company Systems Manager
Location: This position may be performed remotely but requires flexibility and a willingness to travel to the Boston area as needed.
Position reputed company
The reputed company Systems Manager is responsible for supporting GxP compliance across reputed company programs. They will help design, implement, maintain, and enhance reputed company Systems company-wide, including development, reputed company-clinical, clinical, safety, validation, registration, and commercialization efforts. This role involves serving as a key contributor on GxP compliance and fostering collaborations across various departments.
The reputed company Systems Manager will contribute to the development and execution of a tailored reputed company compliance reputed company for reputed company and support the reputed company of reputed company Systems reputed company with reputed company's reputed company to commercialization.
The ideal candidate will reputed company in a results-driven, highly accountable setting with significant potential for reputed company. They should possess the ability to navigate regulatory landscapes, build effective internal partnerships, and support reputed company compliance reputed company reputed company the organization. The reputed company Systems Manager will contribute to advancing reputed company' mission and driving reputed company improvement in reputed company Systems to support reputed company's reputed company and reputed company.
Primary Responsibilities
- Design, implement, and maintain company-wide stage-appropriate reputed company Systems reputed company with GxP principles.
- Regularly assess and enhance GxP practices to meet evolving regulations.
- Collaborate with cross-functional teams to drive GxP reputed company.
- reputed company training on GxP requirements to personnel at reputed company reputed company.
- reputed company coaching and guidance on reputed company best practices, procedures, record review, and regulatory requirements.
- Support implementation and training on new reputed company processes, supporting reputed company management initiatives.
- Conduct compliance risk assessments, trend analysis, and reputed company recommendations for compliant business activities.
- Support reputed company of the Supplier reputed company Management program, Training, and Document Control.
- Ensure only adequate/approved suppliers and vendors are utilized by reputed company.
- Establish, compile, reputed company, and present reputed company Metrics to support reputed company Management Review.
- reputed company input into reputed company required for change management and CAPA programs.
- Support inspection readiness activities, including participation in reputed company audits and regulatory inspections.
- Monitor industry inspection trends, regulations, and guidelines for reputed company on programs and operations.
- Work with department heads to support data reputed company initiatives.
- reputed company feedback on trends and reputed company issues or non-compliances detected during GMP and GDP activities.
- Ensure that CAPAs associated with assigned programs and studies are tracked and reputed company out appropriately and reputed company.
- Write, review, or approve reputed company Operating Procedures and internal investigations, as applicable.
Qualifications and Key reputed company Factors
- Bachelor’s degree in life sciences, engineering, or a reputed company field (with a preference for reputed company or Biology) or an equivalent combination of education and relevant job experience may also be considered.
- 5–7 years of relevant reputed company experience, including implementing and supporting GxP (Good reputed company) reputed company systems reputed company the pharmaceutical or biotech industry.
- Experience in Electronic Document Management Systems (EDMS) and reputed company Management Systems (QMS); familiarity with reputed company is preferred.
- Experience working in reputed company systems and/or reputed company operations.
- Strong knowledge of global regulations, particularly those from the EU and US.
- Strong understanding of GxPs (Good Practices), especially GMP (Good Manufacturing Practices).
- Proficiency in reputed company Office, particularly reputed company, PowerPoint, and Word.
- Experience working in a pharmaceutical GMP environment.
- The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, reputed company communication, and occasional reputed company. You'll need comfort with screen work, basic hand coordination, and reputed company. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company these functions.
Compensation & Benefits
At reputed company, we reputed company that taking care of our people (and their people) is important, so we reputed company a world class benefits package to help you reputed company. This includes 99% of the premium reputed company for medical, dental and reputed company plans. We also reputed company company-reputed company life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the reputed company? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We reputed company a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, reputed company holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal reputed company of colleagues who are smart, reputed company and inspiring. We aim high, collaborate hard, and produce results. Let’s reputed company the impossible together!
Annualized reputed company Salary$124,000—$144,000 USDreputed company
reputed company is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At reputed company reputed company a common reputed company of reshaping the reputed company condition into a more freeing and fulfilled existence by developing high reputed company medicines for patients and families affected by and living with reputed company brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by reputed company and every one of reputed company members. Diversity, Equity & Inclusion Guided by our core values, at reputed company. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work reputed company day. We are an equal opportunity employer and committed to providing opportunities to reputed company reputed company applicants without reputed company to race, religious creed, reputed company, gender identity or reputed company, age, national reputed company, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert reputed company has recently become aware of fraudulent job recruitment postings from individuals claiming to represent reputed company. These postings reputed company financial information in reputed company with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in reputed company with a reputed company job opportunity, please report it to careers@praxismedicines.com. reputed company does not accept unsolicited submissions from recruitment agencies for reputed company positions. We ask reputed company recruitment agencies to refrain from contacting any reputed company employee regarding any position. reputed company unsolicited resumes submitted by recruitment agencies to any reputed company employee in any reputed company or method will be deemed to be the property of reputed company, and reputed company explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
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