Quality Compliance Manager (Sellersville)
Piramal Pharma SolutionsSellersville, PA, US17 hours ago
Job type
- Part-time
Job descriptionMaintain eQMS platforms and act as a system administrator (e.g. ComplianceWire, TrackWise, Ensur, eBMR, eForms). Training Program Oversee all site training activities and provide guidance and training to end-users. Build training programs working with department heads and SMEs to create and revise training curricula. Document Control Oversee SOP program. Responsible for document management (e.g., Master Batch Record, protocol Review and approve quality system records in Trackwise Compliance Systems Provide guidance and work with stakeholders from various departments for on-time completion of quality system records such as deviations, CAPAs, Change Controls, and training records. Annual Product Review (APRs) Lead QSC review boards such as Deviation Review Board, CAPA Review Board, Change Control Review Board Provide quality systems metrics on weekly, monthly and quarterly basis. Complaint / FAR / Recall management Quality Technical Agreements (QTAs) Supplier Management Program Audit Management Program (Internal, External, Client, and Regulatory Authorities) Data Integrity Program Manage Computer System Validation (CSV) program. Site Data Integrity Compliance Officer (DICO) with responsibility over data integrity program. Support site quality improvement projects and electronic systems implements / updates. Work with corporate quality team for continuous improvement and implementation of Global Policies and Procedures Adhere to set safety standards. Other QSC activities as assigned. Bachelor degree or higher in relevant scientific quality assurance / technical field Ability to organize time and drive project tasks for multiple areas (major projects and daily functions). Good written, verbal and interpersonal communication skills. Basic computer skills such as Microsoft Office 10+ years experience in a Manufacturing environment, QA, Quality Systems, and / or Compliance experience in a cGMP / FDA regulated environment with 5 or more years in a supervisor / manager role.
Manager Quality Compliance
Job Description
Position Name : Manager Quality Systems & Compliance
Department : Quality Systems
Location : Sellersville, PA
Position Summary : The Manager Quality Systems & Compliance ensures compliance with global regulatory requirements governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products at PPL Healthcare LLC - Sellersville. This position will support overall cGMP and regulatory compliance at the site by ensuring that the quality systems are used effectively to support the company quality policy and objectives while driving continuous improvement.
To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and / or ability required :
- In depth knowledge of global pharmaceutical regulations (e.g., FDA, EMA, PDMA, ANVISA, TGA, DEA)
- In depth knowledge of Quality Management Systems and Quality Compliance for non-sterile pharmaceutical manufacturing
- Experience with eQMS including DMS, LMS, and eBMR.
- Experience with audit, supplier management, and data integrity.
- Strong teamwork and communication skills
Key Responsibilities
Minimum Education Qualification
Functional or Technical Skills
Minimum Experience (in Years)
Create a job alert for this search
Quality Compliance Manager • Sellersville, PA, US
Related jobs
Focus on the core content of the job post, removing all extra metadata, navigation mentions, and other non-essential information.
Keep the content beautiful and concise, ensuring a high signal to no...Show moreLast updated: 30+ days ago
Braun US Device Manufacturing LLC.Allentown, Pennsylvania, United States.Wednesday, Tuesday, Thursday, Friday, Monday.Other key product areas include nutrition, pharmacy admixture and compounding, ...Show moreLast updated: 6 days ago
US-FL-West Palm Beach | US-CA-Irvine | US-FL-Jupiter | US-PA-Conshohocken.Allied Universal, North America's leading security and facility services company, offers rewarding careers that provide you...Show moreLast updated: 26 days ago
Avantor is looking for an experienced and passionate Operations Manager to optimize our Performance Materials team in the salts business that is delivering results against some of the most complex ...Show moreLast updated: 21 days ago
We are always looking for the best, most qualified people to join our team.Pre-employment drug testing (EOE).Aggregate & Asphalt Quality Control Technician - South Reading.Aggregate and Asphalt Qua...Show moreLast updated: 30+ days ago
We are always looking for the best, most qualified people to join our team.Pre-employment drug testing (EOE).Project Manager to support public and private projects.
The Project Manager plans, direct...Show moreLast updated: 30+ days ago
Position Name : Manager Quality Systems & Compliance.Position Summary : The Manager Quality Systems & Compliance ensures compliance with global regulatory requirements governing the manufactu...Show moreLast updated: 4 days ago
EMCOR Facilities Services (EFS), an EMCOR core business, services over 1 billion square feet of space worldwide.From corporate campuses to single sites, EFS provides a range of services that suppor...Show moreLast updated: 7 days ago
Uline Way, Allentown, PA 18106.Morning Call’s Top Large Employer of 2025!.Taking our tech team to new levels! Join us as an IT Manager to ensure Uline’s Pennsylvania facilities are properly equippe...Show moreLast updated: 18 days ago
Allentown (6580 Snowdrift Rd), Pennsylvania, United States.Wednesday, Tuesday, Thursday, Friday, Saturday, Rotating, Monday, Sunday.
Braun Group of Companies in the U.Along with the nations largest ...Show moreLast updated: 6 days ago
A company is looking for a Senior Manager Software Quality Assurance.Key Responsibilities Define QA strategy and vision aligned with business goals Develop and manage QA budgets, resource planni...Show moreLast updated: 4 days ago We are always looking for the best, most qualified people to join our team.Pre-employment drug testing (EOE).Project Manager to support public and private projects.
The Project Manager plans, direct...Show moreLast updated: 30+ days ago We are always looking for the best, most qualified people to join our team.Pre-employment drug testing (EOE).Certified Payroll Compliance Specialist.
Certified Payroll Compliance Specialist.Based in...Show moreLast updated: 25 days ago 
We are always looking for the best, most qualified people to join our team.Pre-employment drug testing (EOE).Certified Payroll Compliance Specialist.
Certified Payroll Compliance Specialist.Based in...Show moreLast updated: 5 hours ago
The QC Manager oversees all aspects of quality control and calibration across machining operations.This role ensures compliance with internal standards and customer requirements, manages inspection...Show moreLast updated: 5 days ago
At EisnerAmper, we look for individuals who welcome.EisnerAmper is looking to hire a.Risk and Compliance Services practice as a dedicated member of the National Security Advisory services team.The ...Show moreLast updated: 30+ days ago
Job Title : Quality Assurance Specialist, Change Management Location : Souderton, PA Hours / Schedule : M–F, 8 : 00 AM – 5 : 00 PM (First Shift) Compensation : $65,000-$78,000 annually Type : Contract-to-Hire...Show moreLast updated: 3 days ago
Growing Manufacturing Firm / High Growth Opportunity!.This Jobot Job is hosted by : Billy Mewton.Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary : $...Show moreLast updated: 5 days ago
- Promoted
Manager Quality Systems & Compliance
PiramalSellersville, PA, USFull-time
- Promoted
Sr. Quality Engineer
B. Braun US Device Manufacturing LLCAllentown, PA, United StatesFull-time
- Promoted
Director of Compliance
Allied UniversalConshohocken, PA, United StatesFull-time
- Promoted
Operations Manager
AvantorPhillipsburg, NJ, United StatesFull-time
- Promoted
Aggregate & Asphalt Quality Control Technician - South Reading
The H&K Group CareersBirdsboro, Pennsylvania, USFull-time
- Promoted
Project Manager
The H&K GroupDouglassville, PA, United StatesFull-time
- Promoted
Quality Compliance Manager
Piramal Pharma SolutionsSellersville, PA, USFull-time
- Promoted
Quality & Compliance Manager
EMCOR GroupNorristown, PA, USFull-time
- Promoted
IT Manager
UlineWescosville, PA, USFull-time
- Promoted
Manager - Environment, Health, Safety and Security
Central Admixture PharmacyAllentown, PA, United StatesFull-time
- Promoted
Senior Manager Software Quality Assurance
VirtualVocationsPhiladelphia, Pennsylvania, United StatesFull-time
- Promoted
Project Manager
The H&K Group CareersDouglassville, Pennsylvania, USFull-time
- Promoted
Certified Payroll Compliance Specialist
The H&K Group CareersSkippack, Pennsylvania, USFull-time
- Promoted
- New!
Certified Payroll Compliance Specialist
The H&K GroupSkippack, PA, USFull-time
- Promoted
QC Manager
BEC Machine ProductsHarleysville, PA, United StatesFull-time
- Promoted
Senior Manager - CFIUS Security Compliance Advisor
EisnerAmperPhiladelphia, PA, United StatesFull-time
- Promoted
Quality Assurance Statistical Process Control Specialist
JouléSouderton, PA, USFull-time
- Promoted
Continuous Improvement Manager
JobotAlburtis, PA, USFull-time