Director, Quality

Precision For Medicine; United Kingdom; Remote; GBP 80,000 - 120,000; Full time

Job summary

A leading company in the healthcare sector is seeking a Director of Quality to manage audit programs and ensure compliance with regulations. This fully remote position requires extensive experience in clinical research and quality assurance, focusing on strategic compliance development and mentoring team members.

Qualifications

• 10 years of experience in clinical research with emphasis in Quality Assurance/Compliance.
• CRO, Pharmaceutical and/or medical device experience.
• Working knowledge of GCP/ICH guidelines and FDA regulations.

Responsibilities

• Manage Quality and Compliance functional activities, including implementation of the QMS.
• Perform ICH/GCP quality reviews/audits to ensure overall compliance.
• Support and mentor Quality & Compliance team members.

Skills

Leadership

Interpersonal Skills

Problem-Solving

Communication

Attention to Detail

Education

Bachelor’s degree in a science, healthcare or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

1 day ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Precision for Medicine is hiring Director, Quality based in Europe. The position can be covered fully remotely from one of our European locations: UK, Spain, Poland, Slovakia, Hungary, Serbia or Romania.

Position Summary:

The Director, Quality manages the audit program and supports clinical projects to ensure compliance with regulations and Precision procedures.

Essential functions of the job include but are not limited to:

• Manage Quality and Compliance functional activities, including implementation of the QMS, inclusive of SOPs, Training and CAPAs
• Work closely with the Quality and Compliance staff and Operations to provide strategic compliance development advice and guidance for optimal conduct of clinical trials and performs ICH/GCP quality reviews/audits to ensure overall compliance with applicable regulations.
• Initiate the process of follow-up when suspicion of suspected scientific misconduct/serious non- compliance
• Support and mentor Quality & Compliance team members
• Audit regulatory documents for submission to the Food and Drug Administration (FDA) and global regulatory authorities (e.g. MHRA)
• Provide ICH/GCP guidance, auditing advice and training to internal and external clients
• As part of the Management Team help counsel on and direct quality initiatives to Provide ICH/GCP compliance guidance throughout the clinical development life cycle enhance/ensure quality is assessed and maintained cross-functionally
• Support and enhance Precision’s Corporate Compliance functions and facilitate business development and proposals for these areas as the need arises, including bid defense meetings and project kick-off meetings
• Lead system, site, documentation & Trial Master File audits to ensure compliance with internal
• SOPs/project plans and industry standards
• Review/audit documents intended for submission to the FDA to assure compliance with regulatory standards
• Build upon the current QMS in establishing additional company standards and metrics to ensure the highest quality of services provided to clients
• Participate in leading, maintaining and executing the corporate quality initiatives within Precision for Medicine
• Maintains current knowledge of regulations and guidance documents, providing expert analysis to project teams.
• Other duties as assigned

Qualifications:

• Bachelor’s degree in a science, healthcare or related field of study or equivalent
• Requires 10 years of experience in clinical research with emphasis in Quality Assurance/Compliance or equivalent relevant experience and/or demonstrated competencies
• CRO, Pharmaceutical and/or medical device experience
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards
• Availability to travel up to 30% domestically and/or internationally

Skills:

• Strong leadership skills, excellent interpersonal and problem-solving skills, strong verbal and written communication, excellent computer skills
• Demonstrates mastery knowledge of GCP/ICH guidelines, FDA regulations and Precision SOPs - Motivates other members of the project team to meet timelines and project goals
• Ability to review and evaluate clinical data, with advanced proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar database
• Understands financial management to review proposals and budgets
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment
• Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and keen attention to detail
• Ability to work with cross functional groups and management under challenging
• situations
• Ability to prioritize work and handle multiple and/or competing assignments
• Fluent in English language, with excellent verbal and written communications skills

Any data provided as a part of this application will be stored in accordance with our Privacy Policy.For CA applicants, please also refer to ourCA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail].

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Technology, Information and Internet

Referrals increase your chances of interviewing at Precision For Medicine by 2x

Sign in to set job alerts for “Director of Quality” roles.

Director of Quality Improvement - 35 hours per week, home based in the North West - Driver essential

London, England, United Kingdom 20 hours ago

Associate Director, Therapeutic Area Quality Lead - Americas/EMEA - Remote

England, United Kingdom $120,000.00-$140,000.00 39 minutes ago

Operations Director - Professional Services SME

Balsall Common, England, United Kingdom 2 weeks ago

Senior Director, Production_Monopoly GO!

INT Operations Director, Payments (Fraud & Risk)

Senior Scientific Director - Medcomms & Publications

Associate Director, Business Development, Patient Safety & Quality

Senior Director, Global New Business - Scientific Communications

Senior Scientific Director - Publications

Retailer Client Service Director, UK & Ireland (FMCG Industry)

Somerset, England, United Kingdom 5 days ago

Retailer Client Service Director, UK & Ireland (FMCG Industry)

Somerset, England, United Kingdom 1 month ago

Global Private Client Director - Rare & Luxury Whisky

Director of Operations – Remote | Personal Development Industry | Leadership & Growth

Birmingham, England, United Kingdom 5 days ago

Mobile Game Director | North America | Canada | Europe | Fully Remote

Associate Director, Qualitative Research

London, England, United Kingdom 2 weeks ago

London, England, United Kingdom 2 days ago

Outsourcing Art Director - Cosmetics | North America | Europe | Fully Remote

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.