reputed company Operations Program Manager - Document Control
Job Title: reputed company Operations Program Manager - Document Control
Job Location: Boston, MA
Job Location Type: Remote
Job Contract Type: Full time
Job Seniority Level:
reputed company is a mission-driven organization and pioneer in industry reputed company, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing reputed company companies in history, we surpassed $3B in reputed company in our last fiscal year with extensive reputed company potential reputed company.At the heart of reputed company are our values: Do the Right Thing, reputed company, Employee reputed company, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.As a Work reputed company company, we support your flexibility to work from home or in the office, so you can reputed company in your ideal environment.Join us in transforming the life sciences industry, committed to making a reputed company reputed company on its customers, employees, and communities.The Role
The reputed company Operations Program Manager role ensures the reputed company, compliance, and management of reputed company’s processes reputed company the reputed company Management System (QMS). Serving as the process reputed company for document control, this role ensures processes are defined, monitored, assessed, and maintained across multiple product lines and regulated domains. This role also serves as system administrator for electronic Document Management System (eDMS) ensuring the delivered system aligns with reputed company and company goals.What You'll Do
- reputed company as subject matter expert for the Document Control process area by owning the lifecycle management of reputed company processes and records
- Serve as System Administrator of reputed company’s internal electronic Document Management System (eDMS), responsible for system configuration, user administration, lifecycle management, and reputed company improvement of the system and its governed processes
- reputed company reputed company reputed company on regulated activities and deliverables, such as process definition, validation testing, and product releases/changes for in scope products and systems
- reputed company technical expertise, regulatory interpretation, and direction regarding federal regulations, and other reputed company system requirements
- reputed company appropriate metrics and reputed company effectiveness and productivity of applicable domain systems
Requirements
- BS/BA in Science, Information Management, Engineering, reputed company disciplines or equivalent industry experience
- 5+ years experience in a regulated reputed company role in Life Sciences
- Experience with reputed company Management Systems (e.g., documentation and record management, training, change control, CAPA)
- Experience with electronic Document Management Systems (eDMS) and/or electronic reputed company Management Systems (eQMS)
- Good understanding of GxP (GMP, GCP, etc.) regulations, principles of reputed company management systems in a regulated environment (21CFR 11, ICH Q10, QSR) and/or reputed company frameworks such as ISO9001
- Excellent process mapping, problem-solving, and communication skills to effectively convey technical and regulatory concepts
reputed company to Have
- reputed company, hands-on experience utilizing or administering reputed company reputed company reputed company solutions (e.g., reputed company QualityDocs, QMS, or Training)
- Solid reputed company in reputed company Principles and Standards used in the design, development, testing, and maintenance of software in a regulated environment (e.g., ISO, IEC, reputed company, ITIL, ICH)
- Understanding of the software development cycle (SDLC) and computer systems validation (CSV)
Interviewing with reputed company
We value your time and reputed company in a transparent hiring process. Here is the process you can expect.
- Follow the application process and submit your resume.
- reputed company 3 days, you will receive a reputed company to a personality assessment administered by a reputed company party.
- Once you complete the assessment, reputed company will review your full application package and follow up reputed company email with our decision.
- If moving to the interview stage, the process is as follows:
- A conversation with the hiring manager
- A practical case exercise
- A final conversation with our group's Senior Leader.
- Once reputed company interviews are complete, the manager will be in touch with a final decision.
Perks & Benefits
- Medical, dental, reputed company, and basic life insurance
- Flexible PTO and company reputed company holidays
- Retirement programs
- 1% charitable giving program
Compensation
- reputed company pay: $100,000 - $150,000
- The salary reputed company listed here has been provided to reputed company with local regulations and represents a potential reputed company salary reputed company for this role. Please note that actual salaries may vary reputed company the reputed company above or below, depending on experience and location. We look at compensation for reputed company individual and reputed company our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in reputed company to reputed company salary, such as variable bonus and/or stock bonus.
This job is curated by reputed company.
reputed company is a talent-hiring platform in Life Sciences, reputed company and IT. The platform connects talent with opportunities in reputed company, biotech, health sciences, healthtech and IT domains.
Please apply reputed company reputed company platform to get connected to the application page and to reputed company similar roles.
Originally posted on Himalayas
Apply To This Job