Principal CGMP Compliance Consultant

4 weeks ago

Southeast Fairbanks, United States Parexel Full time

Parexel's Strategic CGMP Compliance team is known for our unparalleled breadth and depth of expertise globally. Parexel CGMP Compliance offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre-eminent regulatory and GxP (Good Clinical, Laboratory, or Manufacturing Practice) compliance consulting practice in the world, and we are growing

We currently have a home-based opening on our Team for an experienced CGMP Compliance Expert to join the team as a Principal Consultant. This is an incredible opportunity to assist pharmaceutical and biopharmaceutical companies in driving quality; help our clients manage and prepare for FDA GMP inspections and manage post inspection activities; and work alongside some of the best and most experienced regulatory compliance professionals. A truly phenomenal opportunity to apply your expertise while continuing to develop your career

A Principal Consultant will have the knowledge and ability to provide clients with recommendations on how to bring their processes and procedures into compliance with CGMPs and industry best practices; the ability to write clear, concise, objective reports and recommendations; and effectively communicate and interact with our clients at all levels within their organization.


To be successful a Principal Consultant will have specialized experience in the following:

Pre-approval and pre-licensing sterile inspection experience or significant manufacturing facility inspection experience Experience conducting surveillance inspections which have resulted in FDA-483 Inspectional Observations and subsequent OAIs and/or Warning Letters Experience in the following areas is a plus: Preparation of written responses and remediation plans to address FDA-483 Inspectional Observations and Warning Letters Providing on-site guidance during FDA inspections Preparation for Discussion of CGMP Compliance Matters with FDA Playing an active role in Compliance Remediation strategy and implementation Conducting specialized CGMP training ​

Education:

A Bachelor's degree in a scientific, engineering, or related discipline is required. An advanced degree or equivalent is a plus.Ideal candidates for a Principal role with have 12+ years of CGMP experience. Previous experience conducting sterile facility inspections is strongly preferred, but consideration will be given to others with significant manufacturing facility inspection experience.


Knowledge and Experience:

Previous Compliance experience as a Consumer Safety Officer with a regulatory agency (such as FDA, EMA, MHRA) is required. Strong CGMP knowledge is required.


Skills:

High-level consulting skills Critical thinking and problem-solving skillsProject leadership and management knowledgeExcellent interpersonal and intercultural communication skills, both written and verbalMeticulous attention to detail and the ability to spot issues. Client-focused approach to workResults orientationTeamwork and collaboration skillsProficiency in local language and extensive working knowledge of the English languageProactiveNetworkingBusiness acumen and analysisSelf-confidence and control


Domestic and International Travel is required with an expectation of 50% travel averaged over a year.

#LI-REMOTE

  • Director, Technology Quality Assurance

    2 weeks ago

    Southeast Fairbanks, United States Parexel Full time

    Home Based, USAs Director, Quality Assurance you will manage a team of technology auditors and compliance managers responsible for conducting technology audits and hosting technology sponsor audits and regulatory inspections.Accountabilities:Quality Assurance RepresentativeMember of Corporate Quality acts and is recognized as an ambassador for quality across...

  • Manager, Clinical Operations

    1 month ago

    Southeast Fairbanks, United States Parexel Full time

    Job IntroductionAt Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life-changing medicines to patients. We are seeking a Manager, Clinical Operations to join our team. Our Manager, Clinical Operations works toward building a deeper connection and understanding with those who count on us most. Through...

  • Senior Project Quality

    3 weeks ago

    Southeast Fairbanks, United States Parexel Full time

    Home Based, USAs a Sr Project Quality & Risk Lead you will partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise to support operations, leadership and clients.Responsibilities:Analyze key risk indicators and investigate risk signals by...

  • Fairbanks Donor Service Technician/Phlebotomist

    1 month ago

    Fairbanks, United States Blood Bank of Alaska, Inc. Full time

    Job DescriptionJob DescriptionAre you interested in being a part of our collections team as aDonor Service Technician (Phlebotomist)?Perform screenings and phlebotomy of blood donors. Includes taking vitals, asking health history questions to donors, and performing collection of blood.Entry Level. No experience needed.Starting Pay $22.00POSITION SUMMARYThis...

  • Human Resource Administrative Specialist, Senior

    6 days ago

    Southeast, United States Strategic Insight, Ltd. Full time

    Job DescriptionJob DescriptionStrategic Insight, Ltd., is seeking a Human Resource Administrative Specialist, Senior (Staff Associate) to support our PEO IWS client at the Washington, DC NAVY YARD. Mandatory Requirement: ACTIVE SECRET CLEARANCE REQUIRED (due to the nature of this requirement only US Citizens may be considered).The employee supports the...

  • Behavioral Health Division Head Opportunity

    2 months ago

    Southeast, United States Trinity Health Full time

    Trinity Health IHA Medical Group is seeking an experienced, board-certified Psychiatrist to join our multispecialty group in Southeast Michigan to serve as the Division Head for Behavioral Health.The Division Head (DH) for Behavioral Health (BH) will serve as the operational and service line leader for Trinity Health (TH) IHAs growing Behavioral Health...

  • Training & Development Coordinator

    5 days ago

    Fairbanks, United States Alaska Teacher Placement Full time

    Position Type: Other/School Counselor Date Posted: 3/1/2024 Location: STREAM ACADEMY CHARTER District: Anchorage School District Additional Information: Show/Hide Bargaining Unit: AEA Work Year: 182 Days per year Job Summary The school counselor works as part of a team with school staff, parents, and the community to create a caring climate and atmosphere...

  • Cloud and Infrastructure Engineer

    1 week ago

    Fairbanks, United States Upskilled Evolution Full time

    Salary $90-120k/annualized, DOE Uniquely Human, we provide full scale technology sustainment, strategic planning and professional services to our clients, allowing them to achieve their greatest ambitions. We support diversity in all we do and recognize success is achieved by the inclusion of all experiences and voices and is an equal-opportunity employer. ...

  • Medical health and staff

    2 months ago

    Southeast, MI, United States Trinity Health Full time

    Trinity Health IHA Medical Group is seeking an experienced, board-certified Psychiatrist to join our multispecialty group in Southeast Michigan to serve as the Division Head for Behavioral Health . The Division Head (DH) for Behavioral Health (BH) will serve as the operational and service line leader for Trinity Health (TH) IHAs growing Behavioral...

  • Coordinator CIT Social Services

    3 weeks ago

    Fairbanks, United States Alaska Teacher Placement Full time

    Position Type: Other/Coordinator CIT Social Services Date Posted: 3/6/2024 Location: TITLE I District: Anchorage School District Additional Information: Show/Hide Bargaining Unit: ACE Work Year: 184 days per year, 12 contract payments OR 215 days per year, 12 contract payments Work Day: 8 hours per day FTE: Full time, 1.0 FTE Salary: ACE 5, range A to M,...

  • Behavioral Health Division Head Opportunity

    2 months ago

    Southeast, MI, United States Trinity Health Full time

    Trinity Health IHA Medical Group is seeking an experienced, board-certified Psychiatrist to join our multispecialty group in Southeast Michigan to serve as the Division Head for Behavioral Health . The Division Head (DH) for Behavioral Health (BH) will serve as the operational and service line leader for Trinity Health (TH) IHAs growing Behavioral...

  • Senior Tailings Engineer

    7 days ago

    Fairbanks, Alaska, United States Kinross Gold Corporation Full time

    Located approximately 26 miles from the City of Fairbanks, Fort Knox is a centre of excellence for the Company as one of the few cold weather heap leach facilities in the world. Fort Knox celebrated its 25-year anniversary in 2021, and has produced over 8.5 million ounces since it began operation. In 2020, Kinross acquired Manh Choh - a project expected to...

  • Senior Facilities Mechanical Engineer

    1 week ago

    Fairbanks, Alaska, United States University of Alaska Full time

    The DDC team has overall responsibility for the planning and development of all UAF infrastructure and facilities to meet the educational and research needs of our vibrant university and community.As a Facilities Services Mechanical Engineer, you will provide professional engineering services and technical expertise to support the maintenance, utilities,...

  • Human Resources Business Partner

    7 days ago

    Fairbanks, United States Corix Full time

    Job Description Who we are Water is the common thread that connects us all. We deliver vital, safe and reliable services which enable our communities to thrive. Through infrastructure investment and Operational Excellence, we safeguard our natural resources for today and future generations. We've got this! The Nexus Water Group team has an opportunity for a...

  • Mill Manager

    1 week ago

    Fairbanks, Alaska, United States Kinross Gold Corporation Full time

    Located approximately 26 miles from the City of Fairbanks, Fort Knox is a centre of excellence for the Company as one of the few cold weather heap leach facilities in the world. Fort Knox celebrated its 25-year anniversary in 2021, and has produced over 8.5 million ounces since it began operation. In 2020, Kinross acquired Manh Choh - a project expected to...

  • Intake Specialist

    1 month ago

    Fairbanks, United States Restore Incorporated Full time

    Job DescriptionJob DescriptionSalary: DOERESTORE INCORPORATED Behavioral Health Rehabilitation ServicesJob Title:                  SUD/ Rehabilitation Intake Counselor (Substance Abuse/Addiction) Supervisor:               Chief Administrative Officer  Salary:                       DOE                    FSLA...