QA Project Manager
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
Title: QA Project Manager III
Location: Portsmouth, NH
Shift Hours: 40 Hour work week - Mon - Fri
Salary: $56.00 Based on Experience
Employment Type: Long Term Contract (Benefits Available)
Environment: A global leader and trusted supplier in the pharma, biotech and specialty ingredients markets. Headquartered in Basel, Switzerland, the company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities. The company s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.
The QA Project Manager 3 is assigned as the primary liaison to an external customer(s) for all quality-related items including temporary and permanent change controls, deviations, standalone investigations, CAPAs, Product Quality Reviews, and Quality Agreements. Responsible to facilitate discussions between customers and internal groups such as MSAT, Manufacturing, Engineering and QC. For these quality-related items, the Project Manager coordinates the process for notifying the customer and assuring the customer s feedback and comments are addressed, verifies that the quality records are complete; that there is sound justification/scientific rationale, that root cause analysis and corrective and preventive action is appropriate and, where applicable, that customer approval is received. The QA Project Manager 3 leads Joint Quality Team meetings establishes agendas, publishes meeting minutes and tracks action items; participates in Internal and Joint Project Team (IPT/JPT) meetings as the QA representative and tracks and publishes monthly and quarterly quality KPIs.
Key Accountabilities and Duties:
- The Quality Compliance Project Manager 3 interacts directly with internal and external customers on change management, projects, deviations, standalone investigations and CAPAs and contributes to the decision making for compliance related quality issues. The QA PM 3 is capable of reviewing investigation reports and root cause analysis for deviations. The Project Manager will require little minimal supervision for day to day activities. The Project Manager will define the strategy for remediation for escalations/issues and improvement efforts. Mentors less experienced staff on team and will provide direct support to management.
Key Accountabilities and Duties:
- Interact with internal and external customers as part of Joint and Internal project teams serving as the Quality Subject Matter Expert.
- Reviewing and approving various product specific documents, as needed, such as Process Validation reports, Quality Agreements, Annual Product Reviews, Deviation Reports and Change Controls
- Mentorship and Training of other quality team members. Act as Supervisor/Manager delegate when requested. This includes meeting coverage and delegation of tasks to ensure service expectations are being met for all customers
- Support Customer and/or Regulatory audits and Inspections
- Manage and Track Key Performance Indicator Quality Metrics
- Perform other duties as assigned.
Minimum Required Education/Experience:
- Bachelor Degree in Scientific related field or Equivalent Experience
- GMP - 5-10 Years exp.
- Quality Assurance - 3-5 years exp.
- Biotechnology Manufacturing - 0 - 4 years exp.
- Project Management - 0 -4 years exp.
- Ability to balance and prioritize tasks
- Ability to provide guidance and coaching
- Ability to maintain and build internal and external relationships, works effectively individually and with teams
- Questioning attitude and critical thinking required to make quality related decisions
- Displays a clear willingness to listen to others
- Demonstrates quality decision making
- Solid written and verbal communication, good attention to detail