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Universal Health Services
King of Prussia, PA, United States
Responsibilities Join a dynamic organization driven by our passion for healthcare. UHS is seeking talented individuals who are eager to contribute their expertise and pursue rewarding careers. As a leader in acute care and behavioral health, UHS provides high-quality care to over 3 million patients annually, across our national network of faciliti
Job Source: Universal Health ServicesEli Lilly and Company
Philadelphia, PA, United States
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our commun
Job Source: Eli Lilly and CompanyCatalent Pharma Solutions
Philadelphia, PA, United States
The Quality function is to build, monitor, and sustain a robust and effective quality system that delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system establish the requirements for and measure how Catalent complies with all applicable regulations and g
Job Source: Catalent Pharma SolutionsCatalent
Philadelphia, PA, United States
Position: Director Quality Location: Philadelphia, PA Position Summary: The Quality function is to build, monitor, and sustain a robust and effective quality system that delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system establish the requirements fo
Job Source: CatalentWesley Enhanced Living
Hatboro, PA, United States
We are seeking a Sr. Quality Engineer (potential Director of Quality) to define 'quality' in our industry and subsequently implement standards for excellence in care and enhanced living that far exceed the traditional standards of care (e.g., fall prevention, bed sores) that are currently mandated and measured by state agencies. This is a green-spa
Job Source: Wesley Enhanced LivingPiramal Pharma Solutions
Sellersville, PA, United States
The Director, Quality & Regulatory Affairs will maintain Sellersville Quality procedures and systems to ensure regulatory compliance. The incumbent will be an integral member of the Senior Leadership Team. The Director of Quality Operations is responsible for the quality unit at the site and for oversight of all quality related activities at the si
Job Source: Piramal Pharma SolutionsFunction Inc.
, PA, United States
Function of Beauty, Paxinos, Pennsylvania, United States of America Job Description Who We Are: The Perks: Function of Beauty perks includes eligibility for medical, dental, and vision starting the month after you are hired. You also receive short-term and long-term disability, 401(k) with company match, paid time-off, safe and sick time, and d
Job Source: Function Inc.Datwyler
Pennsauken Township, NJ, 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 global markets such as healthcare, mobility, connectivity, general industry
Job Source: DatwylerKing of Prussia, PA, United States
Company Description
We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Job Description
Resource Management and Training:
Participation in QM resource allocation
Resource allocation of QA auditors
Facilitation of professional development and career advancement of Quality Management staff
Administrative supervision of Quality Management staff, jointly with Senior Director Quality Management
Participation in recruitment of Quality Management (QM) staff
Facilitation of initial and ongoing training of Quality Management staff
Oversight of initial and ongoing training of PSI Operations employees in quality management topics
Quality Management:
Facilitation of regulatory agency inspections of PSI
Facilitation of regulatory agency inspections of PSI-managed trial sites, including follow-up
Participation in hosting client/third party audits of PSI, including follow-up
Oversight of CAPA investigations management
Management of investigations of suspected research misconduct, jointly with Senior Director Quality Management
Backup responsibility for review of draft Quality Systems Documents (QSDs), including newly developed and revised QSDs
Backup responsibility for approval of Quality Systems Documents
Oversight of vendor qualification
Oversight of computer systems validation documentation review
Oversight of the process of providing assistance and feedback to all Company staff with regards to various GXP, regulatory compliance, and other QM matters
May act as the primary QM contact for PSI Operations divisions and working groups/task forces with regard to various Corporate projects requiring QM
Quality Assurance Auditing:
Development and implementation of the annual audit plan
Management of QA audits contracted to PSI
Oversight of the preparation and maintenance of internal and contracted quality assurance audits documentation
Business Development:
May be recruited by Business Development for client meetings and vendor shows
Qualifications
College or university degree
MD, PharmD or degree in life sciences is a plus
Minimum 7 years of experience in Clinical Research
Minimum 5 years of industry experience in the capacity of a QA auditor or equivalent
Must have experience in planning, conducting and reporting all types of quality assurance audits
Auditing experience in USA
Excellent knowledge of ICH GCP guidelines, FDA/ EMA regulations, and applicable local regulations
Team oriented with superior communication and interpersonal skills
Strong time management, organizational, planning and presentation skills
Demonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environment
Intermediate proficiency in MS Office (Word, Excel Power Point, Outlook)
Must be a reasonably effective public speaker
Additional Information
All your information will be kept confidential according to EEO guidelines.
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Director, Quality Management jobs in King of Prussia, PA, United States
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