Philadelphia, Pennsylvania, United States · On-site
Associate Director, Quality Assurance Position Summary: This is a full-time salaried position Based onsite out of Philadelphia, PA office The Associate Director, Quality Assurance is accountable for the group providing …
Skills: Quality Assurance, cGMP Regulations, Batch Record Review, Deviation Management, Regulatory Inspections
Hazleton, Pennsylvania, United States · On-site
Imagine a career at one of the nation's most advanced health networks. Be part of an exceptional health care experience. Join the inspired, passionate team at Lehigh Valley Health Network, a nationally recognized, forwar…
Skills: Laboratory Testing, Clinical Laboratory Instrumentation, Quality Control, Preventative Maintenance, Troubleshooting
Erie, Pennsylvania, United States · On-site
$124k–$150k/yr
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every …
Skills: Pharmaceutical Sales, Account Management, Scientific Communication, Cardiovascular Therapeutic Area, Customer Experience (Cx)
Rahway, New Jersey, United States · Hybrid
$191k–$300k/yr
Job Description Our market access team is passionate about bringing our medicines to patients around the world. As a member of the Sac-TMT/Women’s Cancers team, the Director, Oncology Global Market Access will lead globa…
Skills: Collaboration, Commercial Acumen, Cross-Cultural Awareness, Data Analysis, Global Market Access
Horsham Township, Pennsylvania, United States · On-site
EnerSys Advanced Systems (EAS) is a specialized division of EnerSys—a global leader in stored energy solutions for industrial applications. EAS focuses on cutting-edge energy solutions for the aerospace, defense, and med…
Skills: Battery Design, Prototyping, Detailed Drawing, Manufacturing Process Development, Tool and Fixture Design
Pittsburgh, Pennsylvania, United States · On-site
Are you a recent Ph.D. graduate in a STEM or social science discipline interested in a career path in meta-research, knowledge synthesis, open science and/or improving the quality and rigor of research? Join the team of …
Skills: Meta-research, Evidence Synthesis, Open Science, R, Python
Rahway, New Jersey, United States · Hybrid
$173k–$273k/yr
Job Description The Global Clinical Supply (GCS) organization is within our company’s Research & Development (R&D) Division and is responsible for managing the end-to-end integrated clinical supply chain for the R&D port…
Skills: Business Operations, Clinical Supply Chain Management, Coach Team Members, Decision-Making Strategies, Multitasking
Upper Gwynedd Township, Pennsylvania, United States · Hybrid
$117k–$184k/yr
Job Description The Analytical Commercialization Technology (ACT) department within Analytical Chemistry in Development and Supply (ACDS) is seeking an applicant for a Senior Scientist position available at the West Poin…
Skills: Analytical Chemistry, Analytical Method Development, cGMP Regulations, Chemical Synthesis, Chromatography
Rahway, New Jersey, United States · Hybrid
$87k–$137k/yr
Job Description We are seeking a Growth and Improvement minded Engineer in Device Technology that can help drive our Strategic Operating Priorities. Invent | Pursue the Most Promising Internal and External Science to Add…
Skills: Biomedical Engineering, Blow Molding, Business Strategies, Computer Efficiency, Data Matrix
Philipsburg, Pennsylvania, United States · On-site
Location: Geisinger Primary Care Philipsburg Shift: Days (United States of America) Scheduled Weekly Hours: 40 Worker Type: Regular Exemption Status: No Job Summary: Join our team at Geisinger Medical Laboratories. You c…
Skills: Communication, Computer Literacy, Interpersonal Communication, Laboratory Services, Phlebotomy
Allentown, Pennsylvania, United States · On-site
Imagine a career at one of the nation's most advanced health networks. Be part of an exceptional health care experience. Join the inspired, passionate team at Lehigh Valley Health Network, a nationally recognized, forwar…
Skills: Neurodiagnostic Procedures, Electrode Application, Patient Care, ACNS Guidelines, International System of Electrode Placement
Allentown, Pennsylvania, United States · On-site
About the job: The Regional Account Manager (RAM) position is within our Rare Hematology and Nephrology Franchise, a division of Alexion, AstraZeneca Rare Disease and will focus on the launch of IgAN as a potential new i…
Skills: Pharmaceutical Sales, Account-Based Selling, Clinical Acumen, Territory Planning, CRM Tools
Harrisburg, Pennsylvania, United States · On-site
$41k–$59k/yr
APPLICATION INSTRUCTIONS:CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process. Please do not apply here, apply internally throu…
Skills: Archival Processing, Collections Management, Customer Service, Digitization, Metadata Creation
East Pittsburgh, Pennsylvania, United States · Hybrid
The Environmental, Occupational Health. and Safety (EH&S) Specialist supports the implementation and continuous improvement of Holtec's Environmental, Health, and Safety programs by providing technical guidance, conducti…
Skills: EHS Management, Regulatory Compliance, Hazard Assessment, Incident Investigation, Safety Auditing
Spring House, Pennsylvania, United States · Hybrid
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less in…
Skills: Administrative Support, Business Writing, Communication, Customer Centricity, Diary Management
Pittsburgh, Pennsylvania, United States · On-site
About the job: The Regional Account Manager, AHUS/HSCT-TMA position is within our Rare Hematology and Nephrology Franchise, a division of Alexion, AstraZeneca Rare Disease and will focus on aHUS and the potential launch …
Skills: Specialty Pharma Sales, Account Management, Rare Disease Sales, Stakeholder Engagement, Clinical Education
Bethlehem, Pennsylvania, United States · On-site
Imagine a career at one of the nation's most advanced health networks. Be part of an exceptional health care experience. Join the inspired, passionate team at Lehigh Valley Health Network, a nationally recognized, forwar…
Skills: Diagnostic Medical Sonography, Vascular Studies, Patient Care, Quality Control, Imaging Protocols
Scranton, Pennsylvania, United States · On-site
Location: Geisinger Viewmont Imaging Shift: Days (United States of America) Scheduled Weekly Hours: 40 Worker Type: Regular Exemption Status: No Job Summary: Radiologic Technologists are responsible for the administratio…
Skills: Radiographic Procedures, Fluoroscopic Procedures, Patient Safety, ALARA Principles, Vascular Access
Lancaster, Pennsylvania, United States · On-site
Overview If you enjoy working outdoors in a professional and safe environment, consider a career with Bartlett Tree Experts! At Bartlett, we value a strong culture of excellence in safety, scientific research, lifelong l…
Skills: Sales, Client Relationship Management, Tree and Shrub Care Assessment, Arboriculture, Pest and Disease Diagnosis
Montgomery County, Pennsylvania, United States · On-site
Job Details The Phlebotomist is responsible for obtaining patients’ blood specimens through venipuncture, fingerstick or heelstick as appropriate for the performance of requested tests. The Phlebotomist uses appropriate …
Skills: Venipuncture, Fingerstick, Heelstick, Patient Identification, Biohazard Precautions
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The Associate Director of Quality Assurance oversees QA support for clinical and commercial manufacturing operations, including batch record review and deviation management. They serve as the primary quality liaison for clients and lead regulatory inspections and customer audits.
Requires a bachelor's degree in a scientific discipline and at least 10 years of pharmaceutical industry experience, including 4 years of leadership. Proficiency in cGMP regulations and experience with regulatory agencies is required.
Associate Director, Quality Assurance
Position Summary:
This is a full-time salaried position
Based onsite out of Philadelphia, PA office
T he Associate Director, Quality Assurance is accountable for the group providing Quality Assurance support to clinical & commercial manufacturing operations within the facility. This includes but is not limited to shop floor quality, batch record review, deviation management, customer interface, improving activities related to process and support to business demands.
Our Philadelphia facility is our North American Center of Excellence for clinical supply packaging.
Quality liaison for clients and internal customers; is expected to become the owner or escalation point for client requests/issues
Accountable for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus
Participate in Regulatory Inspections and Customer Audits, etc
Participate in site and customer meetings/communications and be directly involved in critical projects/issues
Establishes goals and monitors performance through monthly, quarterly, and annual summaries and metrics
Present summary data to site management on a regularly scheduled basis
Provide QA Technical recommendations based on trend analysis to eliminate future problems
Participates in project meetings to provide input with respect to compliance to cGMP requirements
Other duties as assigned
Bachelor’s degree in scientific discipline, chemistry, biochemistry, biology, microbiology, or chemical engineering, required
Minimum of 10 years’ relevant experience in the pharmaceutical industry
Minimum four years of leadership/management experience with demonstrated ability to set vision and direction for a team including setting expectations and motivating for results to achieve corporate, site and departmental objectives
Working knowledge of cGMPs regulations, required; prefer experience in multiple regions (e.g EU, ANVISA, FDA, Etc.)
Experience working with customers – Contract manufacturing experience, preferred
Prior experience working with quality control, or GMP manufacturing/packaging, preferred
Prior experience working directly with regulatory agencies and handling inspections, preferred
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience
Why You Should Join Catalent:
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
152 hours of PTO + 8 paid holidays
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement
WellHub - program to promote overall physical wellness
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Championing the missions that matter™. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) and trusted partner to pharma, biotech, and consumer health companies worldwide. We put patients first in everything we do, helping people live better and healthier lives through every product we help develop, manufacture and deliver. With over 1,000 active development programs at any given time, we launch over 100 new products and line extensions annually. Catalent has supported half of all FDA approvals over the past decade, and our teams working at over 40 global sites help us produce over 60 billion doses every year. Our strength lies in our people: teams across our more than 40 sites and thousands of passionate scientists and technicians who bring expertise in development sciences, delivery technologies, and multi-modality manufacturing. What unites us is our commitment to championing our partners’ missions as our own, anticipating customer needs, solving complex challenges and ultimately making a difference in the lives of patients across the globe. At Catalent, you will be able to directly have an impact, solving problems and ensuring excellence for our customers. Our focus on delivering meaningful outcomes alongside our customers means your work directly impacts millions of people around the world. Join us in championing the missions that matter. Catalent is headquartered in Tampa, Florida, with over 40 global sites. Visit www.catalent.com to learn more.
Offices: 101 E Kennedy Blvd, Tampa, Florida 33602, US · 14 Schoolhouse Road, Somerset, NJ 08873, US · Frankland Road, Blagrove, Swindon, Wiltshire SN5 8YG, GB · 4-9-17 Akasaka, Minato-ku, Tokyo 107-0052, JP · 160 Pharma Dr, Morrisville, NC 27560, US
Based on 1173 listings with disclosed salaries, most science & research jobs in Pennsylvania pay between $73k–$224k per year. Individual offers vary with seniority, company size, and specialization.
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