Senior Director, Quality Assurance and Compliance

i3 Pharmaceuticals, LLC • Warminster, PA • 19h ago

Senior Director, Quality Assurance and Compliance for i3 Pharmaceuticals, LLC to work at our Warminster, PA loc. Responsible for all internal and external activities of Quality Assurance + Compliance Department. Oversee all daily activities in Department incl scheduling, assigning, + managing QA staff + direct reports. Develop, implement, + continuously improve Quality and Compliance Systems consistent w/ FDA + other regulatory agency reqs. Manage QA + Compliance systems to ensure raw materials + drug products meet company standards. Oversee + manage internal + external audit + vendor/service provider qualification/audit programs. Create + review GMP docs incl SOPs, Annual Product Quality Reviews, risk assessments, supply chain map, + quality reports. Oversee deviations + investigations (quality + laboratory) incl root cause analysis + Corrective + Preventive Action (CAPA) proposals + initiatives. Collaborate w/ cross functional departments incl Product Development, Analytical + Quality Control, Operations, Regulatory Affairs, + Sales + Marketing departments to ensure timely submission of targeted products to FDA + timely launch of commercial products + distribution of approved products. Manage all quality aspects of scale up, exhibit, process validation + commercial batches incl enhancement. Oversee, implement + enhance Quality training programs. Ensure departments follow Standard Operating Procedures (SOPs). Release ANDA exhibit batches for regulatory submissions + clinical studies + release commercial products for distribution. Review standards + specifications for raw materials, in-process + finished products. Ensure full compliance w/ FDA regulations, incl current Good Manufacturing Practices, current Good Laboratory Practices, + other applicable FDA + regulatory agency requirements. Determine, check, + agree on in-house quality procedures in manufacturing, analytical, quality control, compliance, + research + development departments. Oversee validation activities + IQ/OQ/PQ. Prepare documents for regulatory submissions + address FDA deficiencies. Participate in FDA + other regulatory agency inspections. May undergo background checks and drug testing. Must have Bach in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or rel field, 10 yrs relevant quality exp in generic pharmaceutical industry, and required skills (10 yrs exp). Alternatively, must have Masters in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or rel field, 7 yrs relevant quality exp in generic pharmaceutical industry, and required skills (7 yrs exp). Required skills: GLP and cGMP documentation; developing and maintaining SOPs and pharmaceutical industry related documents; managing internal and external audit programs; interpreting and applying FDA regulations; and working within pharmaceutical industry's legal rules and regulations. Apply at i3pharmaceuticals.com/CurrentJobOpenings

Similar Jobs

Channel Sales Associate - Bank

Paychex • Philadelphia, PA • 5min ago

Finance, Accounting & Banking

Imagine Your Future with Us! Since 1971, Paychex has been at the forefront of simplifying HR, payroll, and benefits for American businesses. Our digital HR technology and advisory solutions cater to the changing needs of...

5min ago

Go to Apply

Commercial Banking Manager

Accenture • Philadelphia, PA • 9min ago

Finance, Accounting & Banking

Accenture is a leading global professional services company that helps the world's leading businesses, governments, and other organizations build their digital core, optimize their operations, accelerate revenue growth,...

9min ago

Go to Apply

Restaurant Crew

Raising Cane's USA LLC • North Wales, PA • 3h ago

Retail & Hospitality

We are hiring immediately for Restaurant Crew to work all shifts: opening shifts, closing shifts and everything in between. Whether you have experience as a customer service associate, retail team member, cashier, restau...

3h ago

Go to Apply

Medical Assistant

ChenMed • Philadelphia, PA • 3h ago

Hospital & Medical

We're unique. You should be, too. We're changing lives every day. For both our patients and our team members. Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts? Do you inspire...

3h ago

Go to Apply

Medical Assistant

ChenMed • Philadelphia, PA • 3h ago

Hospital & Medical

3h ago

Go to Apply

Medical Director

American Red Cross • Philadelphia, PA • 3h ago

Hospital & Medical

Please use Google Chrome or Mozilla Firefox when accessing Candidate Home. By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spirit at its best. Are y...

3h ago

Go to Apply

Physical Therapist, Home Health

BAYADA Home Health Care • Souderton, PA • 11h ago

Hospital & Medical

When you know Home is the future of Healthcare Jefferson Health at Home by BAYADA was founded on the principle that healthcare gets better when people get better care at home - the place where they feel best. We are curr...

11h ago

Go to Apply

Physical Therapist, Home Health

BAYADA Home Health Care • Bensalem, PA • 11h ago

Hospital & Medical

11h ago

Go to Apply

Physical Therapist

Health Advocates Network • Philadelphia, PA • 11h ago

Hospital & Medical

Benefits We Offer: Comprehensive health, prescription, dental, vision, life, and disability plans Competitive pay rates Referral opportunities ? Refer a friend & Cash in! Travel reimbursement and per diem allowances...

11h ago

Go to Apply

Physical Therapy Aide

ATI Physical Therapy • Doylestown, PA • 11h ago

Hospital & Medical

Overview Join a collaborative team dedicated to delivering exceptional patient care as a Physical Therapy Aide , while gaining valuable healthcare skills that can launch your career. Work alongside leading experts in Phy...

11h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.