Innova Solutions is immediately hiring for a QUALITY MANAGER


Job Title: QUALITY MANAGER

Location: New Brunswick ,NJ
Duration: 12 months
Pay Range*: $44- $46 per hour.


As a QUALITY MANAGER you will:


Job Description:

The Quality Systems Manager will act as end-to-end Local Process Owner of one or more Quality Systems used within Global External Manufacturing
Establish and maintain relationships and communication pathways with Global Process Owners and Global Process Leads for relevant systems
Act as primary ExM representative at Global Community of Practice meetings
Gather stakeholder input from within ExM on any Global Process changes or initiatives and represent the input back into the Global Network
Own all elements of the process including relevant procedures / forms, training materials, SharePoint content, metrics where applicable
Display technical knowledge of the process and understand risks/weaknesses in the system
Responsible for ensuring the elements of the process are compliant with Regulatory requirements, Health Authority expectations and with policies / global procedures where applicable
Regularly review the process (trends metrics, trends observations, right first time (RFT), Design, optimization) for their effectiveness and provide feedback to the Quality management team for action and remediation
Own relevant process issues - speak to trends / issues / exceptions at External Manufacturing Tier 3A and 3B Quality Council.
Develop and implement pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillance
Processes include Deviation Investigations, Corrective Action / Preventive Action (CAPA), Complaints, Change Control, Quality Risk Management, Documentation, Training, Audits & Inspections.
The Quality Systems Manager will be responsible for providing day-to-day support to ExM Operations on Quality Systems that enable business objectives to be achieved. This may include:
Processing of Customer Complaint records, including escalation of expedited complaints
Support the processing of deviation investigations, CAPAs and change controls
Perform initial impact assessment of Global change controls that may impact ExM Operations
Participate in Virtual Plant Team (VPT) meetings as appropriate
Support the risk assessment and mitigation plans of Contract Manufacturing Organizations (CMO), as required
Facilitate tracking of CMO Health Authority inspection observations and CAPAs
Escalate any emerging trends / issues to the VPTs, as required.
Provide Quality input ad hoc queries relating to ExM Operations
The ideal candidate will have:

A science related degree in Chemistry, Engineering or Biotechnology or equivalent
Experience in infinity/Veeva Vault
Experience with handling product complaints, change control and documentation in pharmaceutical/medical industry.
Minimum of four (4) years' experience in a pharmaceutical Quality related role, preferably within a Quality Systems team
Strong working knowledge of GxP regulations in the European Union (EU), United States (US) and other relevant global markets

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.


We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.


Thank you!


Aritra Roy

4702230481

Aritra.Roy@innovasolutions.com


PAY RANGE AND BENEFITS:


Pay Range*: $44- $46 per hour.


*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).


ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.


Recent Recognitions:

One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
ClearlyRated® Client Diamond Award Winner (2020)
One of the Largest Certified MBE Companies in the NMSDC Network (2022)
Advanced Tier Services partner with AWS and Gold with MS
Website: https://www.innovasolutions.com/


Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws