Quality Compliance Manager (Saranac Lake, NY)
- Effectively communicates and proactively seeks resolution to compliance matters in accordance with internal and regulatory requirements
- Communicates the status of unresolved compliance matters to stakeholders
- Ensures the completion of review/audit of daily reports including, but not limited to final reports, protocols, and nonconforming event reports
- Oversees controlled Quality documents
- Identifies areas for improvement to policies and processes, assesses effectiveness of current policies and processes, and recommends changes
- Provides professional and objective feedback to authors, study directors, technicians, and supervisors on quality and regulatory matters
- Drafts, revises, and approves SOPs
- Manages OOS and deviation events including but not limited to CAPA response reports, client notification, including tracking and reporting of OOS and deviations
- Manages customer complaints including but not limited to investigating and communicating CAPAs to effected parties
- Conducts and/or supports internal audits, client audits, and regulatory audits including, but not limited to coordinating audit scheduling, audit preparation, audit execution, audit response/resolution, and audit follow-up
- Establishes and maintains Quality agreements with clients and suppliers
- Supports education and training on the business on compliance awareness developing and providing quality training, including, but not limited to, GMP orientation, ongoing quality training, and annual regulatory training
- Conducts and/or supports Risk Assessments
- Prepares, maintains, analyzes, and presents metrics related to the quality systems and for tracking regulatory compliance of operations
- Builds collaborative team environment within the department and amongst other company departments
- Leads projects and implements quality initiatives in line with department and organizational goals
- Completes and reports on assignments within the agreed upon timeframe
- Acts as a back up to Quality Lead on an as needed basis
- Trains and mentors department personnel
- Supervises departmental personnel including but not limited to scheduling, time off approvals, ensuring training requirements have been met, staff development, succession planning, and performance management
- Remains current in the field by review of relevant regulatory and compliance literature and attendance at appropriate seminars and conferences.
- Additional duties as assigned
- Works independently and proactively
- Ability to adhere to a standard timeline and resolve issues in a timely manner
- Proactively communicates progress and furthers understanding amongst colleagues and supervisors
- Meets testing timelines in a reliable and efficient manner
- Problem solving and conflict resolution skills in a cross functional setting
- Ability to drive and meet project timelines individually and by coordinating the work of others
- Updates training materials and trains others as appropriate
- Subject matter expert in respective field
- May serve as a delegated backup for senior staff when requested
- Possesses working knowledge of regulatory environment and industry standards
- Coordinates test record review
- Bachelor’s degree from an accredited college/university in microbiology, biology, or a relevant field
- 5+ years' experience in the biotechnology industry with increasing scientific and leadership responsibilities
- Ability to handle multiple tasks and projects under deadline pressure
- Able to adapt quickly to change
- Strong organizational and time management skills
- Highly analytical with strong attention to detail
- Excellent verbal and written communication skills
- A results-oriented team player
- Proficient with Microsoft Office Suite or related software
- Prolonged periods of sitting on a chair, working at a desk and working on a computer and/or telephone
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