QA Operations Manager
4 weeks ago
**Summary**:
Reporting to the QA Operations Head, the QA Manager is accountable for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures.
**About the Role**:
Quality Assurance Operations Manager
Location: Millburn, NJ #LI-Onsite
Shift: 2nd Sun-Wed
Key Responsibilities:
- Oversight of all production and testing activities, ensures compliance with cGxP, including data integrity and eCompliance
- Support exception investigations Review and approval of production, QC and records
- MBR review
- Support OpEx improvement projects Qualified Person
- Executes and oversees batch release in compliance with registration
**Essential Requirements**:
- Bachelor’s degree in Life Sciences. Master’s degree a plus.
- 5 years of experience in GMP Pharmaceutical Manufacturing, with at least 3 years combined of relevant experience in Aseptic GMP Manufacturing Operations and/or Quality Assurance covering GMP manufacturing operations.
- Experience in leadership in roles
- Proven track record and practical experience in supporting a GMP Manufacturing Operations unit and operating in full compliance with global cGMP requirements. Successfully managed inspections by major Health Authorities (e.g. US FDA, EMA).
- In-depth knowledge of cGMP, FDA regulations (21 CFR Parts 211), and ICH regulations. In depth knowledge of QC regulations.
- Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity.
The pay range for this position at commencement of employment is expected to be between $107,200 and $160,800 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
**Commitment to Diversity and Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Division
Operations
Business Unit
Pharmaceuticals
Location
USA
Site
Millburn
Company / Legal Entity
U469 (FCRS = US469) AAA USA Inc.
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
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