Sr. Process and Systems Optimization Specialist (Quality and Compliance - Life Science industry)
Pharmaceutical Product Development (PPD)
- Providing R&D Quality support to Affiliate Medical teams
Serves as subject matter expert to design, develop, deliver and improve products, programs, and services in order to optimize processes, behaviors, performance and audit readiness. Accountable for assigned initiatives aimed at supporting and/or ensuring quality operational delivery via efficient and effective processes, associated systems, training and communications. Interprets data on complex issues, leads teams and makes good business decisions with support.
Essential Functions and Other Job Information:
- Procedural Support
- Review, monitor and approval of controlled process documents for quality, compliance, and commitment gaps, in co-ordination with Sub Process Owners (SPOs) or Process Owners (POs)
- Compliance Support
- Review, assess, monitor and approve process deviations
- Lead investigation and assist in Root Cause Analysis of Quality Issues (QI) and CAPA
- Review and approve Quality Issues (QI)
- Assist the CAPA owner in performing Root Cause Investigations, review and approve CAPA actions
- Monitor CAPA to completion
- Audits and Inspections
- Pre-Inspection Support
- Inspection Readiness Training
- Mock Interview sessions
- Pre-Inspection Doc request and review
- During Inspection support
- Inspection Doc Request support
- Control Room support
- Post-Inspection Support
- Lead CAPA plan completion
- CAPA Monitoring to Completion
- Pre-Inspection Support
- Ensure R&D Quality Management System maintenance in the Affiliate Medical Teams
- Support Affiliate Functional Learning Liaison in the maintenance of R&D QMS matrix, inform Functional Learning Liaison (FLL) of new hires and role changes in Affiliate Medical teams that affect R&D QMS activities
- Ensure Affiliate Medical Teams have available nominated Affiliate PON representative and CAPA Functional Approver
- Support Affiliate Medical Teams in the management of Medical GxP vendors
- First point of contact for Affiliate Medical teams for R&D Quality-related questions
- Assist Affiliate Medical teams with R&D Governance meetings and reports
- Serve as overflow support for large scale global audits and documentation requests, when needed
- Monitor KQI/KPI’s at the affiliate level related to these Quality activities
- Proactively collaborates with initiative leads and management to prepare organize, coordinate, document and/or provide the development and delivery of department products and services to a globally dispersed, cross-functional audience in support of business outcomes and industry compliance requirements.
- Develops varied support materials, presentations, and/or tools to support department's remit and strategies.
- Proactively collaborates with initiative leads and management to develop, optimize and improve processes, associated systems/applications, training and communications.
- Leads small to medium-scale process improvement initiatives.
- Develops process improvement processes and solutions.
- Identifies and collates information required to assess compliance with processes and to prioritize business process improvement needs.
- May review, assess and update procedural documents for overall compliance with current processes.
- Performs special projects, assignments and administrative tasks per business needs.
- Provides training and guidance to junior team members.
A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position.
Education and Experience:
- Degree in Life Sciences or Engineering
- Minimum 2 years of experience in CAPA management and Quality Audit/Inspection support activities
- Fluent in English - read, write, speak. Fluency in additional languages (such as Spanish, Portuguese, Chinese, Japanese etc.).
- Experience in TrackWise or other electronic Quality Management Systems (eQMS)
- Experience in electronic Document Management System (eDMS)
Knowledge, Skills and Abilities:
- Thorough understanding of procedural documents
- Strong understanding of process improvement fundamentals
- Solid investigative and analytical skills
- Strong negotiation skills
- Thorough understanding of clinical management technology and systems, and strong computer skills
- Effective judgment, decision making, escalation, and risk management skills
- Effective oral and written communication skills including the ability to communicate in English, both orally and in writing
- Strong interpersonal skills and problem solving ability
- Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting
- Strong attention to detail
- Thorough understanding of regulatory guidelines and directives
- Strong creative and critical thinking skills
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel. (Recruiter will provide more details.)
Clinical Research Jobs
Clinical Trial Coordinator
Trial Patient Payment Associate II
Biometrics Project Manager / Delivery Lead
Senior Director, Biostatistics - APAC region
Senior Health Economics Consultant
Clinical Vendor Contracts Analyst - FSP
Clinical Contracts Analyst II
Senior Contracts Specialist
Lab Data Specialist I
Associate Manager, Study Start Up (FSP)
Financial Analyst II