Senior Manager Quality Compliance
2 weeks ago
Summary:
The Process Documentation Management CW is responsible for delivering quality leadership in process documentation for significant internal change initiatives. This role provides clear quality requirements for processing documents, exemplifies strong partnership skills, and ensures compliance and timely completion of documentation creation and revisions.
Responsibilities:
- Set strategy for R&D controlled document management at project or program level to best enable the R&D Strategy in partnership with applicable Global Process Owners
- Ensure compliance with Document hierarchy and standards for R&D
- Oversee and provide quality input for the development of clinical trial processes and standards that lead to controlled documents that describe end-to-end processes
- Adapt and implement technical and digital technology solutions to further compliance and end user ability to follow standard documentation
- Lead all aspects of and ensure that R&D controlled documents meet the regulations and any additional obligations / regulatory commitments, putting effective document content controls in place to ensure compliance
- Partner with other Quality functions to ensure robust and aligned quality and compliance advice on good documentation practices and other quality aspects (e.g. planned deviations and inspection readiness)
- Identify, prioritize and remediate gaps in the Quality Management System related to process document management
Basic Qualifications:
- Doctorate degree and 2 years of R&D or Quality experience Or Master's degree and 6 years of R&D or Quality experience Or Bachelor's degree and 8 years of R&D or Quality experience or associate degree and 10 years of R&D or Quality experience Or High school diploma / GED and 12 years of R&D or Quality experience
- 2 years of leadership experience leading teams, projects, programs or advising the allocation of resources
Preferred Qualifications:
- Bachelor's degree in appropriate field or other advanced degree (Preferred)
- Significant experience in Quality Management, Document Management, Compliance, or other relevant areas of pharmaceutical/biotech industry
- Document and process management experience
- Change management expertise
- Clinical Trial experience and/or knowledge of ICH GCP
Pay Transparency: The typical base pay for this role across the U.S. is: $50.00 - $55.00 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
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