Director of GMP Quality Assurance - Conshohocken, PA, United States - Madrigal Pharmaceuticals

Madrigal Pharmaceuticals Conshohocken, PA, United States

1 week ago

Description

This position will be responsible for Quality Assurance oversight of all analytical aspects.

The primary responsibilities will be to ensure quality and accuracy of analytical data and compliance to approved methods and regulatory filings.

This position will participate in technology transfer, participation in audits and inspections, and being an effective liaison to internal cross-functional groups, QA/CMC consultants, and external partners.

This position reports into the Executive Director of GMP Quality Assurance.

Position Responsibilities:

Work collaboratively with internal CMC group and the analytical departments of vendors to obtain analytical reports and relevant raw data.

Review and approve analytical development and validation protocols and reports for QA.Review, and approve as applicable, analytical methods for QA.Review analytical reports including, but not limited to CoA's, QC Reports, Stability Reports for data accuracy and compliance to approved methods, protocols and specifications as applicable.

Implement and maintain a system for internal specifications for API intermediates, final API, and drug product.
Participate in change control process for analytical methods and specifications.

Participate in OOS investigations and approve the final investigation for QA.Archival of all analytical documentation in Madrigal's document system (Veeva QualityDocs).Support creation of or revision to sections in regulatory submission that pertain to analytical data.

Ensure that analytical methods, protocols, and specifications are in compliance with applicable regulatory guidance and standards (e.g., ICH, USP, CFR, EP).Participate in the disposition process for API intermediates, final API, and drug product.

Maintain required knowledge of applicable regulations, guidelines, and company standards and procedures.
Provides input to regulatory responses.
Participate in preparations for (corporate and third-party) inspection-readiness.

Qualifications and Skills:

Strong GMP knowledgeStrong experience in directing or overseeing all aspects of analytical testing, from method development through validation and routine testingAbility to make rational, timely, and compliant risk-based decisionsBS and/or MS in a scientific disciplineSkilled in developing collaborative internal and external relationshipsExcellent troubleshooting skills with the ability to solve complex problemsVisionary leadership skills and ability to interact with all levelsStrong knowledge and experience in leading the design, development, and/or reviews of CMC QA standards and procedures (i.e., policy documents and SOPs).Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications.

Knowledge of FDA regulations and ICH Guidelines in the pharmaceutical and/or biotech manufacturing environment.

Compensation:

Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands.

The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.

SummaryLocation:

Conshohocken, PA, United StatesType:
Full TimeExperience: ExperiencedDepartment: Quality Assurance

Quality Assurance Manager

3 days ago

Extremity Care Conshohocken, United States

**Purpose**: · The Quality Assurance Manager is responsible for ensuring that all products and services meet established quality standards. · **Duties & Responsibilities**: · - Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriat ...
Quality Assurance

2 weeks ago

Parkside Informationstechnologie Philadelphia, United States

Fur Software, die sich auf Dauer bewahrt Um zusatzliche Kosten zu vermeiden, den ROI zu erhohen und sicherzustellen, dass ein bestimmtes Softwareprodukt die Erwartungen vollstandig erfullt, ist es von entscheidender Bedeutung, einen klar definierten QA-Prozess zu haben und diesen ...
Quality Assurance

1 week ago

People Logistics Swedesboro, United States

**People Logistics is seeking quality assurance technicians for our warehouse in Swedesboro, NJ** · **Pay rate**: $15.50 · **Shift available**: · - First Shift 4:00 AM until finish · - First month: Mon-Fri (Training period only), after training weekends will be mandatory · **Esse ...
Quality Assurance

1 week ago

People Logistics Swedesboro, United States

People Logistics is seeking quality assurance and control associates for our warehouse in Swedesboro, NJ · **Starting pay rate**: $17.68 per hour · **Shifts**: · - **First shift 4:30am start Days off Wed/Thu**: · - **Second Shift, 2:00 pm Start, Days off Sun/Fri**: · **Essential ...
Quality Assurance Associate

1 week ago

CORA Services Inc Philadelphia, United States

**DUTIES AND RESPONSIBILITIES**: · - Assist IBHS and ABA Staff with facilitation of IBHS and ABA service delivery to clients through administrative support. · - Maintain service-related documentation in client records by collecting and entering client service data in internal and ...
Director of Quality Assurance

1 week ago

Basil Consulting Group Warrington, United States

**TITLE**: Director of Quality Assurance · **TYPE**: Direct Hire · **LOCATION**:Warrington, PA · **ONSITE/REMOTE/HYBRID**: Onsite · **START DATE**: April 2024 · **SHIFT**: Day · We are a growing company looking for a Director of Quality Assurance. This role will be hands-on and o ...
Quality Assurance Specialist

2 days ago

Dätwyler Pennsauken, United States

In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive globa ...
Quality Assurance Manager

4 days ago

LHH Conshohocken, United States

Our client in Conshohocken is hiring a Quality Assurance Manager to join their team · Job Type: Full-Time/Permanent · Hours: Monday – Friday, 8:00 AM – 5:00 PM - Onsite 5 days/week · Reports To: Director of Quality Assurance · Summary · The Quality Assurance Manager holds a pivot ...
Quality Assurance Manager

1 day ago

C.H. Robinson Conshohocken, United States

Represent C. H. Robinson for all matters of quality and standards with heavy focus on healthcare industry verticals Serve as the subject matter expert and escalation for customer engagement, resulting in the development and coordination of action pla Quality Assurance, Manager, A ...
Quality Assurance Manager

1 week ago

LHH Conshohocken, United States

Our client in Conshohocken is hiring a Quality Assurance Manager to join their team · Job Type: Full-Time/Permanent · Hours: Monday Friday, 8:00 AM 5:00 PM - Onsite 5 days/week · Reports To: Director of Quality Assurance · Summary · The Quality Assurance Manager holds a pivo ...
Quality Assurance Manager

1 week ago

Extremity Care Conshohocken, United States

Job Description · Job Description Salary: $80, $85,000.00 per year · Purpose: · The Quality Assurance Manager is responsible for ensuring that all products and services meet established quality standards. · Duties & Responsibilities: · Maintain a working knowledge of FDA 21 CF ...
Director, Quality Assurance

1 week ago

Tandigm Health West Conshohocken, United States

Tandigm Health, a transformational leader in population health management, is looking for a Director, Quality Assurance in the greater Philadelphia area. We offer a competitive compensation and benefits package and are proud to share a culture of diversity and inclusion. · Primar ...
Quality Assurance Manager

16 hours ago

Extremity Care Conshohocken, United States

Job Description · Job Description Salary: $80, $85,000.00 per year · Purpose: · The Quality Assurance Manager is responsible for ensuring that all products and services meet established quality standards. · Duties & Responsibilities: · Maintain a working knowledge of FDA 21 C ...
Quality Assurance Assistant

1 week ago

Dwyer Professional Services Swedesboro, United States

Job Description: Responsible for and assisting with various Quality office functions Main · **Responsibilities**: · 1. Executing QC special customer requirements prior to shipment which includes customer portal work, bar code generation, special inspections, documentation upload, ...
Quality Assurance Employee

1 week ago

Crimson Ventures Camden, United States

Your responsibilities include the following tasks: · As an employee in quality assurance, you are a competent contact person for technical questions from the site managers, from the planning phase to documentation · You accompany and analyze the planning, execution, and documenta ...
Quality Assurance Manager

2 days ago

LHH Recruitment Solutions Conshohocken, United States

Job Description · Job DescriptionLHH Recruitment Solutions is seeking a Quality Assurance Manager, for a full-time, Direct Hire position in Conshohocken, PA. This is a great opportunity with an organization who is seeking an experienced candidate to start immediately The anticipa ...
Quality Assurance Technician

1 week ago

Quantum Innovations New Philadelphia, United States

We are Trio Personalmanagement - your regional personnel service provider. · Our entire management team, employees and staff bring many years of experience in the areas of temporary employment, recruitment, sales, customer service, recruiting and employee care, and are dedicated ...
Quality Assurance Manager

1 week ago

Extremity Care Conshohocken, United States

Job Description · Job DescriptionSalary: $80, $85,000.00 per year · Purpose: · The Quality Assurance Manager is responsible for ensuring that all products and services meet established quality standards. · Duties & Responsibilities: · Maintain a working knowledge of FDA 21 CFR 12 ...
Quality Assurance Manager

3 days ago

Extremity Care Conshohocken, United States

Job Description · Job DescriptionSalary: $80, $85,000.00 per year · Purpose: · The Quality Assurance Manager is responsible for ensuring that all products and services meet established quality standards. · Duties & Responsibilities: · Maintain a working knowledge of FDA 21 CFR 12 ...
Global Quality Assurance Man Home and Personal Care

2 days ago

Nouryon Radnor, United States

**Global Quality Assurance Director, Home & Personal Care**: · The Quality Assurance Director will be responsible for setting, communicating and overseeing the creation and maintenance of a best-in-class quality management system for all internally and externally sourced products ...