- 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
- 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
- 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.
- Previous Compliance experience as a Consumer Safety Officer with a regulatory agency (such as FDA, EMA, MHRA) is required.
- Strong CGMP knowledge is required.
- High-level consulting skills
- Critical thinking and problem-solving skills
- Project leadership and management knowledge
- Excellent interpersonal and intercultural communication skills, both written and verbal
- Meticulous attention to detail and the ability to spot issues.
- Client-focused approach to work
- Results orientation
- Teamwork and collaboration skills
- Proficiency in local language and extensive working knowledge of the English language
- Proactive
- Networking
- Business acumen and analysis
- Self-confidence and control
-
Reg Compliance Consulting Director
Found in: Jooble US O C2 - 4 days ago
CNA Boston, MA, United StatesAnd we have the leadership to help you get there. CNA seeks to offer a comprehensive and competitive benefits package to our employees that helps them - and their family members - achieve their physical, financial, emotional and social wellbeing goals. · Requires and applies sen ...
-
Senior Medicare Clinical Compliance Consultant
Found in: Lensa US 4 C2 - 3 days ago
Blue Cross Blue Shield of Massachusetts Hingham, United StatesReady to help us transform healthcare? Bring your true colors to blue. · What we need: · As an integral part of HMM Quality and Compliance team, the Senior Medicare Clinical Compliance Consultant works through the influence as an individual contributor while collaborating and p ...
-
Senior Medicare Clinical Compliance Consultant
Found in: Careerbuilder One Red US C2 - 3 days ago
Blue Cross Blue Shield of Massachusetts Hingham, United States Full timeReady to help us transform healthcare? Bring your true colors to blue. · What we need: · As an integral part of HMM Quality and Compliance team, the Senior Medicare Clinical Compliance Consultant works through the influence as an individual contributor while collaborating and pr ...
-
Senior Medicare Clinical Compliance Consultant
Found in: Lensa US 4 C2 - 2 days ago
Blue Cross Blue Shield of Massachusetts Hingham, United StatesSenior Medicare Clinical Compliance Consultant page is loaded · Senior Medicare Clinical Compliance Consultant · Apply locations Hingham time type Full time posted on Posted 3 Days Ago job requisition id R07057 Ready to help us transform healthcare? Bring your true colors to blu ...
-
Marketing Intern
Found in: SonicJobs Direct Apply US - 4 days ago
Fresenius Medical Care Waltham, United States Full timePURPOSE AND SCOPE: · Utilizes marketing skills, knowledge and expertise to manage and coordinate assigned marketing projects, working closely with the Sales team to ensure effective execution of marketing strategies to support growth of the business. Project responsibilities enc ...
-
Associate Scientific Services Support
Found in: SonicJobs Direct Apply US - 1 day ago
Actalent Cambridge, United States Full timeGreat opportunity to get your foot in the door with one of the top scientific companies in the Cambridge, MA area · If interested, please reach out directly to Lindsee Allienello at lallienello @ · Job Description Summary: · Candidate to provide critical lab support at a custo ...
-
QC Equipment Service Provider
Found in: SonicJobs Direct Apply US - 1 day ago
Actalent Norwood, United States Full timeJob Description: Quality Control Equipment Provider · Role Overview: · The Quality Control Equipment Provider plays a critical role in ensuring the accuracy, reliability, and compliance of analytical equipment used in quality control laboratories. This individual is responsible f ...
-
director, ehs business partner
Found in: Careerbuilder One Red US C2 - 1 day ago
Entegris, Inc. Billerica, MA , USA, United StatesJob Title: · Director, EHS Business Partner · Job Description: · Here at Entegris, we use advanced science to enable technologies that transform the world, and we are seeking employees who have the drive to continue that mission. · The Role: · Entegris is seeking a Director, EHS ...
-
Manager of Production and Supply Chain Planning, Master Scheduler
Found in: Appcast US C2 - 1 day ago
Randstad Billerica, United StatesSupply Chain Production and Planning Manager plays a pivotal role in overseeing the coordination, execution, and optimization of the production and planning processes within the supply chain. Primary responsibility of this role will be to support the production planning processes ...
-
Corporate Counsel
Found in: Careerbuilder One Red US C2 - 1 day ago
Bruker Billerica, United States· Corporate Counsel · Job Locations · US-MA-Billerica · ID · # of Openings · 1 · Job Function · Legal · Overview · Bruker Corporation enables scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker's high-performanc ...
-
Accounting Manager
Found in: Lensa US 4 C2 - 5 days ago
ASM Pacific Technology Billerica, United StatesAs an Accounting Manager for ASM NEXX, Inc., you will work alongside the Senior Team to drive the strategy and success of our business. A successful leader in this role will develop and lead the accounting team, be a strong cross-functional collaborator, an exceptional communicat ...
-
Accounting Manager
Found in: Lensa US 4 C2 - 6 days ago
ASM Pacific Technology Billerica, United StatesAs an Accounting Manager for ASM NEXX, Inc., you will work alongside the Senior Team to drive the strategy and success of our business. A successful leader in this role will develop and lead the accounting team, be a strong cross-functional collaborator, an exceptional communicat ...
-
Director, EHS Business Partner
Found in: Lensa US 4 C2 - 3 days ago
Entegris Billerica, United StatesJob Title: · Director, EHS Business Partner · Job Description: · Here at Entegris, we use advanced science to enable technologies that transform the world, and we are seeking employees who have the drive to continue that mission. · The Role: · Entegrisis seeking a Director, ...
-
Director, EHS Business Partner
Found in: Lensa US 4 C2 - 2 days ago
Entegris Billerica, United StatesDirector, EHS Business Partner page is loaded · Director, EHS Business Partner · Apply locations Billerica, MA time type Full time posted on Posted Yesterday job requisition id REQ-5267 Job Title: · Director, EHS Business Partner Job Description: · Here at Entegris, we use adva ...
-
Senior Quality Assurance Auditor
Found in: One Red Cent US C2 - 2 days ago
Parexel International Corporation Billerica, United StatesJoin Parexel's team of changemakers as we help advance healthcare throughout the globe, all while keeping the patient at the heart of everything we do. · At Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life- changing medicines ...
-
Senior Compensation Analyst
Found in: Lensa US 4 C2 - 3 days ago
Connexion Systems & Engineering Billerica, United StatesJob Description Job Description Title: Senior Compensation AnalystHiring Organization: Connexion Systems & EngineeringCompensation, Benefits, and Employment TypeDuration: 6+ months contractPay rate: $40-$50/hrJob Location: hybrid (2-5 days onsite) Billerica, MASchedule: M-F, stan ...
-
Associate Director of Manufacturing
Found in: Lensa US 4 C2 - 2 days ago
Lantheus Billerica, United States· The objective of this position is to provide leadership and management oversight of cold (non-radioactive) product manufacturing technical operations on the Billerica Campus, while ensuring compliance with all GMP, OSHA and other regulatory requirements. · The Associate Direc ...
-
Manager of Production and Supply Chain Planning
Found in: Lensa US 4 C2 - 5 days ago
Lantheus Holdings, Inc. Billerica, United StatesSummary of role · Supply Chain Production and Planning Manager plays a pivotal role in overseeing the coordination, execution, and optimization of the production and planning processes within Lantheus' s supply chain. Primary responsibility of this role will be to support the pro ...
-
HR Administrator
Found in: Lensa US 4 C2 - 4 days ago
AS&E Billerica, United StatesOverview: · Rapiscan Systems, an OSI Systems Company is seeking a temporary HR Administrator based out of Billerica, MA. · We are proud to be a trusted provider of advanced X-ray technologies for ports, borders, military, high-threat facilities and critical infrastructure all o ...
-
HR Administrator
Found in: Lensa US 4 C2 - 4 days ago
OSI Systems Billerica, United StatesOverview · Rapiscan Systems, an OSI Systems Company is seeking a temporary HR Administrator based out of Billerica, MA. · We are proud to be a trusted provider of advanced X-ray technologies for ports, borders, military, high-threat facilities and critical infrastructure all ov ...
Principal CGMP Compliance Consultant - Billerica, United States - PAREXEL
Description
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:
Experience in the following areas is a plus:
Education:
Knowledge and Experience:
Skills:
Domestic and International Travel is required with an expectation of 50% travel averaged over a year.
#LI-REMOTE