Validation Consultant

Job Title-: CSV Consultant

Location -: East Hanover, NJ (Hybrid)

Duration-: 5 Months

Description:

The Validation eCompliance Manager manages the QA activities related to GxP BR Systems to assure BR system processes & applications comply to Novartis computer system validation (CSV) requirements and remain compliant throughout their life cycle in alignment with e-compliance requirements.

The role will work closely with Quality e-compliance associates, IT, technical and Bioanalytical Laboratory business partners to provide knowledge and assure compliance to Novartis and regulatory requirements.

1. Represent BioMedical Research Quality as eCompliance SME on project validation team(s) overseeing expectations associated with validation and qualification strategy and deliverables.

2. Review/Approve Validation and Qualification deliverables for assigned projects.

3. Ensure strong communication within QA organization and with project teams regard-ing expectations, status and any risks/issues.

4. Anticipate, monitor, report and, as applicable, escalate any CSV and eCompliance risks.

5. Other responsibilities as assigned to support the QA role associated with the new laboratory implementation.

Key Performance Indicators (Indicate how performance for this job will be measured)

1. Feedback from key stakeholders (BR Quality, Business partners, System owners).

2. Independent/confident and empowered completion of assignments with minimal management oversight

3. Timely & compliant execution of QA activities to meet project timelines.

4. Demonstrate active collaboration in projects to assure implementation of “best practices” on the domain.

5. Contribute to continuous improvements/enhancements to benefit business.

Required Skills

• Knowledge of analytical methods and software

• Good working knowledge of GLP /GCLP Scientific areas and relevant IT systems.

• Good knowledge of the System Development Life Cycle

• Ability to grasp new technologies quickly.

• Strong risk management skills

Required Education

Bachelor of Science IT/Engineering/Scientific discipline. Equivalent experience may be considered.

Required Languages

Fluency in English (oral and written). Additional languages such as Spanish, French, German considered a plus.

Required Experience

• 6 of practical experience in pharma/Biotech industry

• Broad knowledge of IT/Software/Medical Device regulations including practical experience.

• In-depth knowledge of Industry Quality Standards (GLP, GCP, ICH, FDA Part 11, ISO 13485)

Personal Skill Set:

• Good interpersonal, negotiation and communication skills (written and oral)

• Innovative, analytical, conceptual & detailed oriented mindset

• Demonstrated ability to partake in interdisciplinary projects with a wide range of business functions and successfully work in global cross-functional matrix.

• A clear sense of personal accountability, ability to drive quality culture with partners and a high degree of mutual respect and integrity are essential factors to succeed.

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.

California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.

LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.