- Minimum of 15 years professional working experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC, Regulatory or related compliance experience with at least 5 years aggregate experience performing audits for GMP, ISO or ICH, and hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections.
- Must be an expert Quality compliance auditor.
- Experience with elements of data integrity covering all areas in a pharmaceutical manufacturing environment, including production and QC laboratories, is also crucial, as well as being skilled in quality investigations, root cause analysis, audit reporting and benchmark sharing with a commitment towards quality improvement.
- Experience in sterile manufacturing and aseptic practice is desired.
- Professional auditor training/certification by an organization recognized within the pharmaceutical industry ( IRCA, ASQ).
- Strong foundation of pharmaceutical manufacturing and laboratory operations.
- May be required to support other VVS MA sites as needed.
- Diverse experience auditing a wide range of manufacturing technologies and services in 50% or more of the following areas:
- Strong communication skills including listening, judgment, problem management, ability to lead teams in a sophisticated and global environment.
- Ability to anticipate potential problems and risks related to quality system / regulatory expectations including ability to formulate and implement solutions.
- Strong collaboration and problem-solving skills; and adept at working well within a team environment.
- Capable to conduct remote auditing, when required.
- Strong oral/written communication skills appropriate for diverse international collaboration including excellent fluency in English.
- 40-50% travel based on business needs.
-
Sr Director Biostatistics
2 weeks ago
EPM Scientific Massachusetts, United StatesMy Client, a Growing Biotech is Hiring a Sr Director of Biostatistics What makes this position unique? · Step into the realm of cutting-edge biopharmaceuticals, where innovation knows no bounds. My client, a renowned clinical stage Biopharmaceutical company is looking to bring o ...
-
Director/Senior Director Regulatory CMC
3 weeks ago
EPM Scientific Massachusetts, United StatesThe client is dedicated to developing innovative therapies to address unmet medical needs. We are focused on advancing our clinical pipeline through key regulatory milestones. As a nimble and dynamic organization, we offer a collaborative environment where your expertise will dir ...
-
Director of Support
1 week ago
Carriage Services Massachusetts, United StatesDirector of Support - Funeral Homes (North East) · At Carriage Services we believe in the concept of "First Who, Then What." We have learned that leaders, who attract and surround themselves with the best people, achieve great things. We believe in the Four E's of Leadership—Ener ...
-
Director Quality Assurance
2 weeks ago
ACE Partners Massachusetts, United StatesThe Director of Quality Assurance will oversee the Quality functions including QE, QA, QC, Document Control and Quality Systems. This is a hands-on role where you will be responsible for maintaining ISO 13485 compliance. · Responsibilities: · Support New Product Development fro ...
-
Senior Medical Director, Global Drug Safety
3 days ago
Scienta Massachusetts, United StatesSenior Medical Director, Drug Safety · Company – Global NASDAQ Biotech, Gene Therapy · Location – Massachusetts · About: · Our client is a leading biotechnology company specializing in the development of gene therapy. Their focus is on creating innovative in vivo treatments that ...
-
Managing Director
1 week ago
AmerisourceBergen Services Corporation Massachusetts, United States Full timeOur team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join ...
-
Director, Revenue Recognition
2 weeks ago
Infinera Massachusetts, United States Full timeDescription · Infinera is looking for a motivated candidate to join its revenue team. This role involves proactively collaborating with sales and service management teams to guide on sales transactions & programs to optimize in period revenue recognition while maintaining full c ...
-
Director of Engineering
2 weeks ago
Relate Search Massachusetts, United StatesRelate Search has been retained to assist an Industrial Manufacturer in adding an outstanding Director of Engineering to their team. In this pivotal role, you will report directly to the Vice President and be responsible for overseeing the daily operations of the Engineering depa ...
-
Brooke Charter Schools Massachusetts, United StatesSchool Student Support Manager · About Brooke · Brooke Charter Schools opened as a single middle school in 2002 and has since grown to be a network of three K-8 schools and one high school, serving approximately 2,200 students from Boston and Chelsea. Our mission is to provide an ...
-
Territory Sales Manager
1 week ago
Lucas James Talent Partners Massachusetts, United StatesTerritory Manager - Sleep · Location: Springfield, Massachusetts · Our client is made up of creative and talented associates who are transforming the home medical equipment industry. Their patient-centric business model is founded on innovation through technology and cutting-edg ...
-
Adjustment Counselor
3 weeks ago
NHCS Massachusetts, United States Permanent / Full time· What is the Adjustment Counselor role? · As an Adjustment Counselor / Social Worker, you care deeply about the success of your scholars and create strong relationships to leverage success both in and out of the classroom. You understand the demands of working with behaviorall ...
-
Dean of Culture
2 weeks ago
Libertas Academy Charter School Massachusetts, United StatesDean of School Culture · Libertas Academy Mission · Through rigorous academics, character development, and strong supports for every learner, Libertas Academy Charter School prepares all sixth through twelfth grade students to succeed within the college of their choice and to be ...
-
Practice Lead/Sr. Director
2 weeks ago
Stack Digital Massachusetts, United StatesJob Title: Practice Lead/Sr. Director (Ex.Dir/VP if they have right level of experience) · Employment Type: Permanent · Location: US (Preferably in East coast - NY, NJ, MA, CT) · Note: Need strong experience within HEOR, RWE/RWD. Need experience with Business Development and Sale ...
-
MassMutual Massachusetts, United States Full timeThe Opportunity · The New Business Director will lead a team of Account Managers and Case Managers who are committed to driving strong business results and exemplary customer experience to our Distribution partners and their clients through our various sales channels. · • Accoun ...
-
Director Finance
2 weeks ago
Sedgwick Massachusetts, 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 ...
-
Takeda Massachusetts, United States Full timeDescription · About the role: · The Territory Business Manager will execute sales strategies and demand generation efforts to ensure the attainment of regionally focused objectives for our IG (Immune Globulin) business across the Neuromuscular space in the Boston, MA Territory. ...
-
Rehab Director
3 weeks ago
HealthPRO Heritage Massachusetts, United States Regular Full timeOverview · $100K - $112K · Full Benefits (401K, PTO - 22 Days, Medical, Dental, Vision) · State Licensure Reimbursement · Continuining Education Benefits · Upscale/Posh Skilled Nursing Facility (Masconomet Healthcare) · At HealthPro Heritage we hire people who share our vis ...
-
Resident Services Director, RN or LPN
4 weeks ago
Maplewood Mill Pond LLC Careers Massachusetts, United States Full timeResident Services Director, RN or LPN · Being a part of Maplewood requires passion and a desire to help others. Each employee has the ability to touch the hearts of all our seniors and be a part of something bigger than themselves. Maplewood Senior Living is a state-of-the-art, ...
-
Enterprise Medical Recruiting Massachusetts, United StatesA Boston area community health center that cares for more than 34,000 patients annually has an opening for a Site Medical Director (5 years experience preferred). · About the opportunity · Provide leadership to the clinical staff as well as maintain a clinical practice of 16 ho ...
-
Cook - Food Service / Full time
1 day ago
Oakhill HealthCare Massachusetts, United States Full timeFull Time & Part Time Weekend Day Position · Cook for Oakhill Healthcare · At Next Step Healthcare, we know that working in the healthcare industry is more than just a job – it's a way of life reserved for the most compassionate, caring, and hard-working individuals. We are pri ...
Compliance Director - Massachusetts, United States - Thermo Fisher Scientific
Description
We are looking for a highly skilled pharma-GMP auditor and risk management leader. This leader will have a significant amount of quality auditing experience across diverse technologies, working with systems-based audit approaches that cover all aspects of pharma-GMP systems. We emulate a high degree of integrity, depth and accuracy in our approach, with a dedication to carrying out a premier audit program.
What will you do?
We identify systemic gaps in quality/compliance by conducting internal audits of Thermo Fisher Pharma Services Group (PSG) manufacturing and Clinical Trial Division (CTD) sites. We prepare detailed audit reports to communicate observations written in a meaningful and accurate way, so that readers can easily understand the conditions or gaps in compliance with regulations and quality compliance standards. We maintain knowledge of GMPs, and are routinely aware of revised or emerging quality regulations and their trends, as well as industry methodologies across the globe.
We promote positive Quality and leadership behaviors such as: creating environments for learning, harnessing lessons learned to drive continuous improvement; sharing standard methodologies; maintaining effective and open communication; and encouraging cross-functional partnerships.
We also participate in ad-hoc quality compliance projects related to auditing ( detailed trending reports, data analysis, reviewing global PSG policies, and preparing auditor training materials for
internal/external quality auditors in the PSG network, etc.).
How will you make impact?
Becoming a key player in the mission to holistically assess the state of quality and regulatory compliance across PSG global manufacturing/testing sites via fully independent audit program. Helping to minimize risk across the sites and achieve successful regulatory inspections. Making a contribution toward the success of PSG and the services/products provided to clients and patients.
How will you get here?
Education
Bachelor's Degree in Pharmacy, Science or Engineering required.
Advanced degree in related field preferred.
Experience
Sterile drug products: (liquid, lyophilized vials, prefilled syringes)
Non-sterile drug products: (tablets, powders, capsules, granules, softgels)
Biologics cell culture: upstream (Fed-Batch, Perfusion, XD, etc.) and downstream purification processes (Chromatography, nano filtration, etc.)
Chemicals, intermediates, API manufacturing: (synthesis, purification, drying, isolation, etc.)
Packaging operations: (primary and secondary)
QC laboratories (Analytical and Microbiological)
IT / Computer systems validation
Clinical and commercial stage products and services
Viral vector (VVS) and microbial manufacturing (MMS)
Data integrity audits: (both laboratory and non-laboratory operations)
Knowledge, Skills, Abilities:
