The Quality and Manufacturing Senior Consultant should have 5-10 years of experience in Pharmaceutical, Biotech, and/or Medical Device Commercial Manufacturing and Quality. He/she must have experience leading projects and/or implementations in GxP environments. He or she must be comfortable and proficient in interacting directly with clients on an ongoing basis and managing their expectations. In addition, the candidate should be adept at managing the people, process and technology for eliciting business requirements, translating business requirements into system requirements, and managing clarifications between business and technical teams. Experience with Computer Systems Validation (CSV) and the Solution Delivery Lifecycle (SDLC) are also key qualifications.
FUTURE DUTIES AND RESPONSIBILITIES
• Provides subject-matter expertise and support to Quality & Manufacturing Project and Business Development teams as needed in the following areas:
* Quality Management Systems
* Lab Investigations
* Change Controls
* Supplier Qualification
* Document Management Systems
* GMP Documents (SOPs, Work Instructions, Protocols, Master Batch Records, Forms, etc)
* GCP Documents
* GLP Documents
* Enterprise Resource Planning (ERP) / Manufacturing Execution (MES) Systems
* Quality Transactions (Hold / Quarantine, Material / Batch Status)
* Inventory Management
* Manufacturing Execution
* Batch Record Execution
* Bulk Production
* Intermediate Processing
* Fill / Finish
* Sampling across all phases
* Warehouse Management
* Cold-Chain Management
* Good Distribution Practices
* Drug Supply Chain Security Act (DSCSA Track & Trace)
* Unique Device Identifier (UDI)
* Pharmacovigilance / Patient Safety
* Pre-Market (Clinical)
* Post-Market (Commercial)
* Regulatory Agency Inspections
* Regulatory Agency Audit Hosting & Management
*x`Regulatory Audit Observation Remediation
* Pre-Approval Inspections
• Demonstrates facility in client-facing activities including:
* Eliciting and documenting business requirements.
* Analyzing and validating business requirements.
* Translating business requirements into system and non-functional requirements.
* Facilitating requirements review sessions with business and IT.
* Assists business clients with developing new business processes or modifying existing business processes (during implementation, may help develop communication material; define supporting procedures and standards; document training materials; assist in the immediate training effort; etc.).
* Assists in the creation of business cases and other related financial planning, impact identification, or value justification.
* Consistently delivers on the following internal activities while fostering a collaborative environment:
* Maintains and manages requirements within requirements management tool and related SDLC artifacts.
* Performs or assists with defect or incident root cause analysis in support of incident and problem management processes.
* Performs or assists with other functions including vendor coordination, planning, project management, release management and change management as assigned and actively participates in special projects as assigned.
* Adheres to Solution Delivery Lifecycle (SDLC) and IT Service Management (ITSM) processes.
* Develops the right skills to meet the future needs of the organization.
* Performs or assists with production support as needed.
REQUIRED QUALIFICATIONS TO BE SUCCESSFUL IN THIS ROLE
SKILLS / KNOWLEDGE REQUIRED
• Bachelor’s degree (preferred in Biology, Chemistry, Engineering, Computer Science, or Communications) OR equivalent work experience
• GxP Manufacturing Experience and/or GxP Quality Control / Quality Assurance Experience
• Ability to execute on highly complex assignments of variable size with minimal supervision and oversight
• Ability to coach and mentor others
• Excellent oral and written communication and interpersonal skills
• Highly organized
• Ability to analyze, articulate and solve problems
• Ability to learn quickly, move with agility between assignments, multi-task, and to work effectively in a team environment, both face-to-face and remotely
• Ability to manage small to medium sized teams across multiple projects
• Experience with Enterprise Systems implementations
• Experience executing roles within the SDLC (including author, tester, coordinator, or project manager)
• Requirements development, engineering or management knowledge
• Experience with enterprise requirements management / application lifecycle management tools
- Business Analysis
- Life Sciences
What you can expect from us
Build your career with us.
It is an extraordinary time to be in business. As digital transformation continues to accelerate, CGI is at the center of this change—supporting our clients’ digital journeys and offering our professionals exciting career opportunities.
At CGI, our success comes from the talent and commitment of our professionals. As one team, we share the challenges and rewards that come from growing our company, which reinforces our culture of ownership. All of our professionals benefit from the value we collectively create.
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Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.
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