Validation eCompliance Manager
Apply NowCompany: Synectics Inc.
Location: East Hanover, NJ 07936
Description:
Description :
Qualifications:
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
- The Validation eCompliance Manager manages the QA activities related to GxP BR Systems to assure BR system processes & applications comply to 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 regulatory requirements.
- Represent BioMedical Research Quality as eCompliance SME on project validation team(s) overseeing expectations associated with validation and qualification strategy and deliverables.
- Review/Approve Validation and Qualification deliverables for assigned projects.
- Ensure strong communication within QA organization and with project teams regarding expectations, status and any risks/issues.
- Anticipate, monitor, report and, as applicable, escalate any CSV and eCompliance risks.
- Other responsibilities as assigned to support the QA role associated with the new laboratory implementation.
- Key Performance Indicators:
- Feedback from key stakeholders (BR Quality, Business partners, System owners).
- Independent/confident and empowered completion of assignments with minimal management oversight
- Timely & compliant execution of QA activities to meet project timelines.
- Demonstrate active collaboration in projects to assure implementation of "best practices" on the domain.
- Contribute to continuous improvements/enhancements to benefit business.
Qualifications:
- Bachelor of Science IT/Engineering/Scientific discipline.
- Equivalent experience may be considered.
- Languages: Fluency in English (oral and written). Additional languages such as Spanish, French, German considered a plus.
- 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)
- 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
- 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.
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.