Sr. Manager, GCP Quality Assurance | BioNJ Talent Services

Sr. Manager, GCP Quality Assurance

Contact Information
Contact Name: 
Ferring Pharmaceuticals
Organization Name: 
Ferring Pharmaceuticals
Position Location: 
Parsippany
Company Profile: 

Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with over 5,700 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women’s health (obstetrics/gynecology) and orthopaedics. Ferring’s US operations employ approximately 800 people.

People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.

Job Description:

Summary:

Conducts audits of clinical trial sites, contract research organizations (CRO), suppliers, protocols, investigator brochures (IB) and study reports and reports all audit observations to “sites” and Ferring management. Conducts system and process audits as required, e.g. Pharmacovigilance, data management, and safety.

Provides quality and compliance oversight and promotes quality improvement and relevant harmonization for Clinical Operations according to GQA policy and procedures. Maintains GCP regulatory compliance and quality performance within FIPCUS. Responsible for communicating quality issues to area department head(s) and may communicate to executive management, including resource requirements, to maintain QA compliance. Prevent and mitigate quality risks which can jeopardize Ferring's interests (patient safety, supply continuity, reputation).

Responsibilities:

•Establish audit program for FIPCUS sponsored clinical trials in cooperation with Corporate Quality Audits
•Conducts audits of clinical trial sites, suppliers, protocols, and study reports and reports all audit observations to “sites” and Ferring management
•Conducts system and process audits as required, e.g. Pharmacovigilance, data management, and safety
•Monitor and report audit trends locally. Secure peer review of audit reports with GQA
•Drive a continuous improvement / on-going development mind-set in FIPCUS together with clinical operation’s management and GQA
•Manage Quality metrics and key process indicators reporting through monthly quality reporting, local quality reviews board (QRB) and global QRB meetings
•Execute quality compliance activities: SOP approval, deviation, CAPA and change management, improvement projects
•Establish and execute GCP training programs
•Host local regulatory and health authority inspections

Qualifications: 

Requirements:

•Minimum of a Bachelor of Science degree in Natural Sciences, Pharmacy, or Nursing from an accredited college or university
•A minimum of 8 years of progressively responsible experience within QA functions with at least 5 year’s GCP auditing experience in clinical research, clinical operations, or clinical QA. Biotechnology and / or pharmaceutical industry experience is highly preferred over hospital or academic setting
•Experience and active participation in health authority inspections as well as performing clinical site, readiness inspections
•Experience in a QA leadership role is preferred
•Working knowledge of Pharmacovigilance systems and processes is highly preferred
•MS Office applications and Trackwise
•Extensive knowledge of cGCP QA and compliance programs
•Extensive knowledge of ICH E6 and associated FDA.EU GCP regulations is a must with knowledge of ISO14155 for medical device clinical trials preferred
•Excellent influencing, communication and interpersonal skills, as well as the ability to influence and interact at multiple levels of the organization, manage multiple priorities, and deliver excellent results
•Experience interfacing with regulatory authorities, notified third party audits and either leading or being in a key participant role
•Experience with, or direct knowledge of, several quality system elements (e.g. document management, complaint investigation, CAPA, change control, standards and systems management), and a proven track record of participating in cross-functional teams to achieve significant quality and process improvements is required
•Excellent problem-solver with the ability to make difficult decisions and / or provide sound Quality/Compliance direction with limited supervision
•Strong background in developing quality objectives through effective quality planning
•Ability to educate stakeholders, customers and management

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Quality Assurance