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CGI Technologies and Solutions, Inc. Quality & Manufacturing SME in Plymouth Meeting, Pennsylvania

Quality & Manufacturing SME

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Quality & Manufacturing SME

Category: Testing/Quality Assurance

City: Plymouth Meeting, Pennsylvania, US United States

Position ID: J0721-1920

Employment Type: Full Time

Position Description:

The Director of Consulting Services/ Delivery will be responsible for the overall growth, staffing, management and delivery of highly visible engagements within CGI’s Life Sciences Supply Chain Quality practice. As point person for Quality opportunities and projects, the Quality Lead is pre-eminent in managing project scope in all areas of the project lifecycle (working closely with the project PM). Quality as defined here is focused on the Drug Manufacturing Process. It is not IT Quality, CSV or Corporate Quality. Individuals in this role provide significant business value to the client and are trusted advisors who effectively maintain close working relationships with senior client managers. Quality Lead will drive the development intellectual content for sales, marketing and engagements, serving as the lead professional and ensuring delivery of the highest quality work.

Your future duties and responsibilities:

FUTURE DUTIES AND RESPONSIBILITIES

• Successful individuals will have significant experience within the Bio-Pharmaceutical Manufacturing Quality domain.

• Knowledge of Quality & Manufacturing (good manufacturing practices (GMP)) business process for biotech or pharmaceutical industry. Specific expertise with Document and Change control process is required

• Knowledge and experience leading Quality Management solutions (such as EMC, Veeva, Master Control, Trackwise, eTQ, QUMAS)

• Defining and implementing quality management business processes (e.g., developing quality manuals, interpretations of regulations, policies, and related quality management SOPs). NOTE: QM processes include: mfg. change control, deviations, non-conformances, audit/CAPA, etc.,

• Management of: Production and Process Controls, Equipment and Facility Controls, Records, Documents, and Change Controls

• Material Controls, Design Control Corrective and Preventive Actions

• Assessing and advising clients on quality management gaps, provide recommendations on remediation

• Knowledge of international Health agency (especially US and Europe) quality regulations

• Have experience implementing or managing GMP quality at an organization

• Defining process maps and user requirements for implementing QMS software

• Developing QMS strategy and roadmap deliverables, process maps, and SDLC deliverables for QMS software mainly along with other areas described above

Required qualifications to be successful in this role:

General Qualifications:

• Successful individuals will have significant consulting experience with a recognized professional service organization.

• Leading pursuits (writing / presenting proposals & SOWs, estimating jobs)

• Facilitating workshops with business and IT

• Providing strategic and tactical consulting services to LS firms

• Demonstrated effective client aptitude with strong strategic capabilities

• Demonstrated ability to create effective working relationships with team members

• Outstanding written and verbal communication skills

• Experience with growing revenue or follow on projects

Requirements:

• In addition to delivery, Quality Lead will be responsible for identifying expansion opportunities and additional revenue opportunities within the client working closely with the Engagement Lead for the account

• Demonstrated business management and leadership skills

• Proven experience developing long term relationships with senior executives that lead to account expansion opportunities

• Demonstrated ability to build, maintain and enhance relationships with clients

• Strong project management skills

• Proactively grow CGI’s market presence in quality by playing a key role in successful account expansion/development by identifying perspective client work, architecting sales and closing business with the Engagement and Sales Leads

• Demonstrate thorough understanding of business trends as it relates to quality in life sciences industry

• Holds membership and is active in key industry trade association

• Strategic Analysis across broad eco-systems

• Deep Life Science / Pharmaceutical expertise is REQUIRED

• Strong client relations and communication skills

• Interpersonal and leadership skills

• Ability to articulate the various types of architecture required to implement a new business capability

• Depth in business process improvements, business processing mapping

• Ability to capture business process needs, business drivers through individual discussions, group discussions, and workshops

• Knowledge and experience developing estimating models and solution estimates for complex multi-system environments

• Comprehensive knowledge of hardware, software, application, and systems engineering

• Project and program management planning and organizational skills

• Communication of technical information to business partners, in non-technical language

Skills:

  • Business Analysis

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, pregnancy, 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 .

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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. Qualified applicants with arrest and conviction records are welcome to apply.

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.

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