CGI Technologies and Solutions, Inc. Quality & Manufacturing SME in Plymouth Meeting, Pennsylvania
Quality & Manufacturing SME
- Log in
Find similar career opportunities
Quality & Manufacturing SME
Category: Business Consulting, Strategy and Digital Transformation
City: Plymouth Meeting, Pennsylvania, United States
Position ID: J1119-1954
Employment Type: Full Time
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
Document Management Systems
GMP Documents (SOPs, Work Instructions, Protocols, Master Batch Records, Forms, etc)
Enterprise Resource Planning (ERP) / Manufacturing Execution (MES) Systems
Quality Transactions (Hold / Quarantine, Material / Batch Status)
Batch Record Execution
Fill / Finish
Sampling across all phases
Good Distribution Practices
Drug Supply Chain Security Act (DSCSA Track & Trace)
Unique Device Identifier (UDI)
Pharmacovigilance / Patient Safety
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
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.
Be part of building one of the largest independent technology and business services firms in the world.
Learn more about CGI at www.cgi.com .
No unsolicited agency referrals please.
CGI is an equal opportunity employer.
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.
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at USEmploymentCompliance@cgi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned .
We make it easy to translate military experience and skills! Click here at https://cgi-veterans.jobs/ to be directed to our site that is dedicated to veterans and transitioning service members.
All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held.
CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.