Senior Compliance Manager Job at ACE Partners
Senior Compliance Manager
$120,000 - $130,000 + 15% bonus
Our client is an industry leading pharmaceutical company with headquarters in countries across the globe. They are looking to develop their quality department in Massachusetts and are in need of a Senior Compliance Manager.
Do you have?
- Minimum of 10 years in an FDA regulated industry
- Strong knowledge of 21 CFR Parts 210, 211 and aseptic drug manufacturing
- Experience in managing and developing training initiatives
- Knowledge of SAP, EDMS, LMS, Master Control
- Strong knowledge of trackwise and QMS
- Extensive knowledge of cGMPs, GLPs
- BS in Chemistry or related scientific field
...Then this is an excellent opportunity for you!
You will:
- Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing training for employees to effectively use the electronic Quality Systems
- Design, plan, implement, and manage documentation programs, policies, and procedures
- Provide QA review of Annual Product Reviews (APRs)
- Lead Monthly Quality Review Board (QRB) meetings, Quality Investigation Board (QIB)
- Assist with FDA and other compliance audits including corporate audits.
- Participate in investigation team efforts to determine root cause for critical quality events and recommend appropriate CAPA
If this sounds like the position for you, apply below!
Job Type: Full-time
Salary: $120,000.00 - $135,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Employee discount
- Health insurance
- Life insurance
Schedule:
- 8 hour shift
- Monday to Friday
Supplemental pay types:
- Bonus pay
Ability to commute/relocate:
- Billerica, MA 01821: Reliably commute or planning to relocate before starting work (Required)
Education:
- Bachelor's (Preferred)
Experience:
- FDA regulations: 6 years (Preferred)
- 21 CFR: 3 years (Preferred)
- Aseptic Drug Manufacturing: 3 years (Preferred)
Work Location: One location
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