Manager, Quality Services

ICON is currently recruiting for a Manager, Quality Services to join our Strategic Regulatory & Safety Consultancy group that forms part of a wider Commercialization and Outcomes group. Our regulatory consulting team serves clients around the globe—from biotech startups to big pharma—as well as the research firms that serve them. We’re headed by industry leaders who bring more than three decades of regulatory affairs experience to your projects. They, in turn, are backed by an unsurpassed team of more than 100 professionals and staff.

Manager Quality Services

Reporting to the Senior Director, Regulatory CMC and QA, the Manager Quality Services will support clients in their quality compliance activities, GMP inspections, development of Quality Systems, quality agreements, and product disposition pre- and post-market. The role ensures adherence to current GMPs with a focus on pharmaceutical drugs and biologics.

Responsibilities and Accountabilities:

·         Act as client quality unit in all facets of quality assurance

·         Prepare for, assist in or manage audits conducted by an agency or the client

·         Support client QA activities in plant, as needed, including support in establishing a Quality System, development of procedures, deviation investigation and corrective actions support

·         Manage client projects, including client relationships and project budgets

·         Respond to customer complaints, assist with investigations and disposition of commercial and clinical product

·         Maintain product and client files

·         Prioritize and complete multiple projects within established timeframes

·         Participate in client meetings and teleconferences

·         Maintain current GMP knowledge

·         May be assigned additional responsibilities as needed

Qualifications:

·         Chemistry, chemical engineering, biochemistry or life sciences degree, minimum Bachelors, preferred Masters

·         Minimum 10 years’ experience in pharmaceutical/biopharmaceutical industry (person-in-plant experience is an asset)

·         Comprehensive experience in Quality Assurance including knowledge of current US cGMP (experience in GMP in other jurisdictions is an asset)

·         Working knowledge of pharmaceutical/biopharmaceutical manufacturing processes, analytical testing and validation processes (manufacturing and testing)

·         Good working knowledge of ICH, ISO and US drug legislation and regulatory guidance (knowledge of drug legislation in other jurisdictions is an asset)

·         Strong problem solving and negotiation skills

·         Sound written and oral communication skills, good organizational and planning skills, and effective presentation skills to a variety of audiences

·         Strong computer skills

·         Previous consulting experience is a strong asset

·         Ability to build positive, productive relationships with colleagues and clients

·         Comfortable working in a fast-paced environment and several projects at one time

·         Must be willing to work remotely in a virtual team

·         Must be able to travel for customer audits and client meetings, as required 

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment #LI-AA1