Sr.Life Science Quality & Manufacturing

Category: Business Consulting, Strategy and Digital Transformation
City: Burlington, Massachusetts, United States
Position ID: J1119-1985
Employment Type: Full Time

Position Description

Become a member of CGI as we collaborate with our Life Sciences clients to transform the way they work today and enable their path forward. CGI’s capabilities and our client engagements will offer you an exciting path for growth. We strongly encourage and facilitate our members’ development through various avenues including leading engagements, developing new service offerings, designing solutions, and preparing proposals. Our practice’s focus on the New England region allows our consultants to work predominately with local clients, while CGI’s national and international operations offers opportunities for travel if desired. We are seeking candidates with Business Analyst experience in Life Sciences Quality & Manufacturing and GMP fields, as well as strong consulting, analysis, problem solving and communication skills. If you are looking to make your career journey extraordinary while delivering innovative client projects, come and be a part of CGI’s continued success.

Your future duties and responsibilities

The successful candidate’s responsibilities and duties will include the following:

• Gather requirements through meeting/interviewing client stakeholders, and then documents, analyses, and validates the requirements accordingly.

• Translate business requirements into system and non-functional requirements

• Facilitating requirements review sessions with business and IT.

• Improve systems by studying current practices, identifying opportunities for improvement, and designing modifications to the application or procedures.

• Perform data analysis in order to support problem resolution and recommendation development

• Assist 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.)

• Determine and document recommended software configuration.

• Maintain and manage requirements within requirements management tool and related SDLC artifacts.

• Perform or assist with defect or incident root-cause-analysis in support of incident and problem management processes.

• Build consensus both within the CGI and client teams, and achieve goals through influence

• Develop test cases to ensure user requirements are met and the system performs as expected.

• Develop training material to support rollout of project deliverables; deliver training to the client’s trainers, or client’s end-users

• Assist in the creation of business cases and other related financial planning, impact identification, or value justification.

• Participate in project status meetings, internally and with the client.

• Escalate appropriately critical unresolved issues, including recommendations for resolution.

• 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.

The successful candidate will provides subject-matter expertise and support to Quality & Manufacturing Project and Business Development teams as needed in the following areas:

• Quality Management Systems

• Deviations

• Lab Investigations

• Complaints

• Change Controls

• CAPAs

• Audits

• Supplier Qualification

• Document Management Systems

• GMP Documents (SOPs, Work Instructions, Protocols, Master Batch Records, Forms, etc)

• GCP Documents

• GLP Documents

Required qualifications to be successful in this role

• 5-10 years of experience in Pharmaceutical, Biotech, and/or Medical Device industries in the Quality Management and Manufacturing functions, either directly in industry or as a consultant.

• 2+ years of management consulting, advisory or professional services consulting experience

• A minimum of 5 years relevant Business Analyst experience

• GxP Manufacturing Experience and/or GxP Quality Control / Quality Assurance Experience

• Experience leading projects and/or implementations in GxP environments

• Proficient in interacting directly with clients on an ongoing basis and managing their expectations

• Bachelor's degree in Biology, Chemistry, Engineering, Computer Science, or related field OR equivalent work experience

• Experience gathering business requirements, gap analysis, process flows, road mapping, solution design

• Able to work under tight deadlines

• High attention to detail through proofing, follow through and scheduling

• Ability to execute on highly complex assignments with minimal supervision and oversight

• Thrives in a dynamic work environment balancing priorities for efficient workflow

• Excellent interpersonal, communication (written and verbal) and presentation skills

• Creative thinking and ability to seek innovative solutions to complex technical/business problems

• A team player that is able to put the project or team success before their own, while also developing other members of team

• Adeptness to work collaboratively on a team as well as independently

• 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.

• 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


DESIRED QUALIFICATIONS/NON-ESSENTIAL SKILLS REQUIRED

• Experience with Enterprise Systems implementations, including Veeva

• 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

Desired areas of experience

• 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

• Packaging

• Sampling across all phases

• Warehouse Management

• Cold-Chain Management

• Distribution

• 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

• Regulatory Audit Observation Remediation

• Pre-Approval Inspections

Skills

  • 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.

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 US_Employment_Compliance@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 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.

CGI is committed to the principles of equal employment opportunity and to compliance with US laws and regulations. Click here to access our US EEO/Affirmative action policy.

Applicants have rights under Federal Employment Laws:

  1. EPPA
  2. FMLA
  3. Consolidated EEO Is The Law

 

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 US_Employment_Compliance@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 to be directed to our site that is dedicated to veterans and transitioning service members.