- 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.
-
Compliance Specialist
1 week ago
The University of Alabama at Birmingham Medicine Birmingham, United StatesTo perform internal audits to ensure regulatory compliance in an assigned area. To assist in implementing and maintaining a comprehensive compliance data quality management program. To educate others on regulatory compliance. Bachelor's degree in a r Compliance, Compliance Specia ...
-
Compliance Specialist
2 weeks ago
Altec Birmingham, United StatesResponsibilities · Altec is hiring a Compliance Specialist in Birmingham, AL (Corporate Office). The Compliance Specialist will assist the Compliance Manager with the management of HR Compliance to include governmental reporting, policy oversight and adherence, associate relation ...
-
Compliance Specialist
3 weeks ago
Altec Industries Birmingham, United StatesResponsibilities · Altec is hiring a Compliance Specialist in Birmingham, AL (Corporate Office). The Compliance Specialist will assist the Compliance Manager with the management of HR Compliance to include governmental reporting, policy oversight and adherence, associate relatio ...
-
university compliance specialist
4 weeks ago
The University of Alabama at Birmingham Medicine Birmingham, United StatesTo assist with compliance analysis, review, monitoring, or audits of various aspects of functions performed at UAB, prioritized through University-wide risk assessments or based on emerging regulations, enforcement areas or areas of concern. To provi Compliance Specialist, Securi ...
-
Compliance Program Specialist
2 weeks ago
PNC Financial Services Group, Inc. Birmingham, United StatesPosition Overview · At PNC, our people are our greatest differentiator and competitive advantage in the markets we serve. We are all united in delivering the best experience for our customers. We work together each day to foster an inclusive workplace culture where all of our emp ...
-
Compliance Program Specialist
3 weeks ago
PNC Financial Services Group Birmingham, United StatesJob Profile · Position Overview · At PNC, our people are our greatest differentiator and competitive advantage in the markets we serve. We are all united in delivering the best experience for our customers. We work together each day to foster an inclusive workplace culture wher ...
-
Processor - Driver Compliance Specialist
2 weeks ago
P&S Transportation Birmingham, United StatesJob Description · Job DescriptionCompany Description · Founded in 2004, P&S Transportation is one of the fastest growing flatbed trucking operations with terminals nationwide. We are continuously expanding and improving our services through our commitment to hiring the best and b ...
-
Compliance Program Specialist
1 week ago
PNC Birmingham, United States Full timePosition Overview · At PNC, our people are our greatest differentiator and competitive advantage in the markets we serve. We are all united in delivering the best experience for our customers. We work together each day to foster an inclusive workplace culture where all of our emp ...
-
Compliance Program Specialist
2 weeks ago
PNC Financial Services Group Birmingham, United StatesJob Profile · Position Overview · At PNC, our people are our greatest differentiator and competitive advantage in the markets we serve. We are all united in delivering the best experience for our customers. We work together each day to foster an inclusive workplace culture wher ...
-
Compliance Specialist II
2 weeks ago
Altec Industries Birmingham, United StatesWhy Join Altec? · Altec is an industry leader, providing equipment to electric utility, telecommunications, tree care, construction, and light and signs markets. We help customers dig deeper and reach higher Altecs auction subsidiary, JJ Kane, extends the lifecycle of critical e ...
-
Compliance Program Specialist
4 weeks ago
PNC Financial Services Group Birmingham, United StatesPosition Overview · At PNC, our people are our greatest differentiator and competitive advantage in the markets we serve. We are all united in delivering the best experience for our customers. We work together each day to foster an inclusive workplace culture where all of our em ...
-
IT Compliance Specialist Sr, GRC
3 weeks ago
Sedgwick Birmingham, United StatesTaking care of people is at the heart of everything we do, and we start by taking care of you, our valued colleague. A career at Sedgwick means experiencing our culture of caring. It means having flexibility and time for all the things that are important to you. It's an opportuni ...
-
Compliance & Training Specialist
2 weeks ago
Integra LifeSciences Holdings Corp. Cordova, United StatesChanging lives. Building Careers. · Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's poss ...
-
Real Estate Analyst
2 weeks ago
SCA Health Birmingham, United StatesReal Estate Analyst · JOB_DESCRIPTION.SHARE.HTMLCAROUSEL_PARAGRAPH · JOB_DESCRIPTION.SHARE.HTMLBirmingham, Alabama · Surgical Care Affiliates · Real Estate Services · Regular · Full-time · 1 · USD $52,000.00/Yr. · USD $70,000.00/Yr. · 32945 · Job Description · Overview · Today, ...
-
Travel Nurse
3 days ago
Triage Birmingham, United StatesTriage is seeking an experienced Medical Surgical Registered Nurse for an exciting Travel Nursing job in Birmingham, AL. Shift: Inquire Start Date: ASAP Duration: 13 weeks Pay: $ / Week Travel Med Surg RN | Birmingham, AL · Travel Nursing: Med/Surg Birmingham, AL · Location: Bir ...
-
Travel Nurse
2 weeks ago
Triage Birmingham, United StatesTriage is seeking an experienced Intensive Care Unit Registered Nurse for an exciting Travel Nursing job in Birmingham, AL. Shift: Inquire Start Date: 05/26/2024 Duration: 13 weeks Pay: $ / Week Travel ICU RN | Birmingham, AL · Travel Nursing: Intensive Care Unit Birmingham · Lo ...
-
Travel Nurse
1 week ago
Triage Birmingham, United StatesTriage is seeking an experienced Stepdown Unit Registered Nurse for an exciting Travel Nursing job in Birmingham, AL. Shift: Inquire Start Date: ASAP Duration: 13 weeks Pay: $ / Week Travel Stepdown/PCU RN | Birmingham, AL · Travel Nursing: Progressive Care Unit Birmingham · Loc ...
-
Travel Nurse
2 weeks ago
Triage Birmingham, United StatesTriage is seeking an experienced Neonatal Intensive Care Unit Registered Nurse for an exciting Travel Nursing job in Birmingham, AL. Shift: Inquire Start Date: ASAP Duration: 13 weeks Pay: $ / Week Travel NICU RN | Birmingham, AL · Travel Nursing: Neonatal Intensive Care Unit Bi ...
-
Travel Nurse
5 days ago
Triage Birmingham, United StatesTriage is seeking an experienced Stepdown Unit Registered Nurse for an exciting Travel Nursing job in Birmingham, AL. Shift: Inquire Start Date: ASAP Duration: 13 weeks Pay: $ / Week Travel Stepdown/PCU RN | Birmingham, AL · Travel Nursing: Progressive Care Unit Birmingham · Loc ...
-
Travel Nurse
3 days ago
Triage Birmingham, United StatesTriage is seeking an experienced General Practice Registered Nurse for an exciting Travel Nursing job in Birmingham, AL. Shift: Inquire Start Date: ASAP Duration: 13 weeks Pay: $ / Week Travel RN (uncategorized) | Birmingham, AL · Travel Nursing: Long Term Acute Care Birmingham ...
Senior Quality and Compliance Specialist - Birmingham, 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
gKNmvogg6K