- Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates.
- Understanding of how to plan, prepare and conduct GCP audits independently.
- Proficient in authoring and managing audit documents independently.
- Experience in reviewing and editing QMS related documents, i.e., SOPs, Work Practices, Forms, Training Materials, etc. independently.
- Develop CAPA plans and contribute to resolution of audit findings independently.
- Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently.
- Assists in other duties relating to overall compliance within Quality and Compliance department, as requested.
- Must be willing to travel up to 75% of the time for audits within the US and potential travel to Canada.
- College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years' experience in GCP regulated industry if not a college graduate
- Minimum of 5 years' experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.)
- Expert knowledge of scientific principles and concepts.
- Reputation as emerging leader in field with sustained performance and accomplishment.
- Proficiency with MS Office applications.
- Hands-on experience with clinical trial and pharmaceutical development preferred.
- Good communication skills and willingness to work with others to clearly understand needs and solve problems.
- Excellent problem-solving skills.
- Good organizational and communication skills.
- Proficient with 21 CFR Part 11, FDA, and GxP requirements.
- Expertise within CROs and scientific and clinical data/ terminology, and the drug development process.
-
Program Compliance Specialist I
2 weeks ago
State of Delaware New Castle, United States**Introduction**: · **Make a Difference with DHSS** · Our mission at the Department of Health and Social Services (DHSS) is to improve the quality of life of Delaware citizens by promoting health and well-being, fostering self-sufficiency, and protecting vulnerable populations. W ...
-
Berkley Wilmington, United StatesCompany Details: · Berkley Technology Services (BTS) is the dynamic technology solution for W. R. Berkley Corporation, a Fortune 500 Commercial Lines Insurance Company. With key locations in Urbandale, IA and Wilmington, DE, BTS provides innovative and customer-focused IT solutio ...
-
Compliance Specialist
2 weeks ago
Orbach Affordable Management Philadelphia, United States**Compliance Specialist** · Job description · - Generate initial interview letters and recertification letters when necessary. · - This position calls for 75% of work being done on the computer. · - Reviewing files on the computer is required and not to be printed. · - Train staf ...
-
IT Compliance Specialist
2 weeks ago
Crimson Solutions Camden Point, United StatesAbout us · Specialist IT Compliance (m/f/d) · We, Sparkasse Celle-Gifhorn-Wolfsburg, are the fifth largest savings bank in Lower Saxony with a balance sheet total of around 7 billion euros, more than 1,000 employees and customers. For more information about our savings bank, plea ...
-
RN Compliance Specialist
4 days ago
IntePros Wilmington, United StatesIntepros is seeking a candidate for RN Compliance Specialist with one of our healthcare clients. Candidates will be remote, but need to reside in the tri-state area. PA/NJ License is required for this role. · LPN's with compliance experience considered as well · Compliance Speci ...
-
Compliance Risk Specialist
2 weeks ago
Argent Federal Credit Union Chester, United StatesAt Argent Credit Union, we are dedicated to being our members' trusted financial partner and we are committed to the well-being of our community. Every team member strives to fulfill these goals daily by living our service values: fun, positivity, personal attention, professional ...
-
Aging Compliance Specialist
2 weeks ago
Cape Fear Council of Governments Wilmington, United StatesGeneral Statement of Duties · The primary role of this position is to ensure the execution of and compliance with the Home and Community Care Block Grant (HCCBG) for Brunswick, Columbus, New Hanover, and Pender County. Employee monitors HCCBG funding, pays providers, reports data ...
-
Dot Compliance Specialist
1 week ago
Beverage Distribution Center Inc. Pennsauken, United StatesResponsibilities · The DOT Coordinator will be responsible for ensuring the coordination, maintenance, and compliance with Federal (FMCSA/DOT) regulations for all associates driving commercial vehicles. · - Ensure all files and programs are consistent with Federal regulations and ...
-
Research Compliance Specialist
2 weeks ago
University of North Carolina Wilmington Wilmington, United States EHRA Non-FacultyBrief Summary of Work for this Position · The Research Compliance Specialist's primary responsibilities are to review grant proposals for and advise investigators about potential compliance requirements, coordinating and conducting the RCR training program, managing the RIO webs ...
-
Compliance Admin Specialist
4 hours ago
SPIN Philadelphia, United States**_Accountabilities of a Compliance Administrative Specialist_** · - Maintains SPIN workforce current training and professional development manual files and data based records and preserves archived employee training information. · - Maintains current trainer certification record ...
-
Compliance Program Specialist
4 days ago
SBR Inc Philadelphia, United StatesSupportive Behavioral Resources, Inc. is an agency located in Northeast Philadelphia that provides services to adults with Intellectual Disabilities and Autism. SBR is looking for a motivated professional to create and track programming for the individuals that we support, while ...
-
Paralegal Housing Compliance Specialist
3 weeks ago
Matlock Group, LLC Chester, United StatesWe are hiring a Housing Compliance Specialist to work full-time with a well-known, established and growing organization in Chester, PA. The position would pay based on experience, but could range between $ $30.00/hour. · Job duties: · - Assist with the preparation of specific leg ...
-
Program Compliance Specialist I
2 weeks ago
DelDOT New Castle, United StatesIntroduction · Make a Difference with DHSS · Our mission at the Department of Health and Social Services (DHSS) is to improve the quality of life of Delaware citizens by promoting health and well-being, fostering self-sufficiency, and protecting vulnerable populations. We prior ...
-
Berkley Wilmington, United StatesCompany Details: · Company URL: · Berkley Technology Services (BTS) is the dynamic technology solution for W. R. Berkley Corporation, a Fortune 500 Commercial Lines Insurance Company. With key locations in Urbandale, IA and Wilmington, DE, BTS provides innovative and customer- ...
-
Berkley Wilmington, United StatesCompany Details · Company URL: · Berkley Technology Services (BTS) is the dynamic technology solution for W. R. Berkley Corporation, a Fortune 500 Commercial Lines Insurance Company. With key locations in Urbandale, IA and Wilmington, DE, BTS provides innovative and customer-fo ...
-
Affordable Housing Compliance Specialist
4 days ago
Multi-Family Plymouth Meeting, United StatesResponsible to conduct management and occupancy reviews no less than annually in accordance with HUD requirements, Handbook 4350.3, LIHTC Section 42 Regulations and any other regulatory programs that are set aside for the property. · Responsible to verify compliance with HUD regu ...
-
Ascensus Philadelphia, United States**Section 1: Position Summary** · **Section 2: Job Functions, Essential Duties and Responsibilities** · - Responsible for protecting, securing, and proper handling of all confidential data held by Ascensus to ensure against unauthorized access, improper transmission, and/or unapp ...
-
Compliance Specialist
2 days ago
Jefferson Health Philadelphia, United StatesCompliance Specialists are vital members of Jefferson's dynamic and diverse enterprise compliance team. The Compliance Specialist utilizes their excellent communication, strong problem-solving and decision-making skills to drive key operational activities designed to ensure that ...
-
Compliance Specialist
1 week ago
Motion Recruitment Partners LLC Philadelphia, United StatesOur client, a well known local Philadelphia nonprofit is urgently looking to hire an Invoice/Compliance Specialist to join their team on a HYRID schedule in Philadelphia, PA** This is a 6 month contract to hire on a W2 offering a full benefits package **Required Skills & Experien ...
-
Compliance Specialist
5 days ago
Motion Recruitment Partners LLC Philadelphia, United StatesCompliance Specialist · Philadelphia, Pennsylvania · Hybrid · Contract · $20/hr - $22/hr · Our client, a well known local Philadelphia nonprofit is urgently looking to hire an Invoice/Compliance Specialist to join their team on a HYRID schedule in Philadelphia, PA · **** Th ...
Senior Quality and Compliance Specialist - Wilmington, United States - MMS
Description
Job Description
Job DescriptionMMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma's international awards programs for the last three consecutive years. For more information, visit or follow MMS on LinkedIn.
Job Specific Skills:
Powered by JazzHR
YrgBJ6e9CM