Quality Auditor / Pharmaceuticals ONLY

Overview
Objectives

· Lead development and implementation of the GCP supplier audit and compliance strategy for clinical development programs, GMA and MPG studies.

* COMPLIANCE Experience

* Project management experience in the "Auditing world!"

* Thought Leader. Someone who can provide oversight of vendor provided solutions.

· Serve as primary point person for key GCP strategic partners; lead key supplier quality partnership governance councils and/or internal supplier-related committees

· Liaise with suppliers to provide compliance & management support for identified issues arising within outsourced studies.

* Be the liason between internal and external stakeholders

· Lead and/or participate in GCP sponsor and supplier oversight initiatives related to quality.

• ** GLP, GCP and preferably GVP, NOT GMP audits

ACCOUNTABILITIES:

· Lead the development and implementation of risk-based GCP supplier audit and compliance strategy and manage supplier audits in compliance with GCP and client policies and procedures.

· Audits require advanced auditing skills and may involve technically complex assignments.

· Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CQA management.

· Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures

· Lead and/or support quality governance council meetings

* Liaise and collaborate with internal Client and external business partners to provide guidance and support pertaining to compliance and supplier quality oversight initiatives

· Analyse, report, and present metrics on supplier quality performance to management; recommend any required actions and monitor implementation.

· Lead investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.

· Collaborate with Quality Compliance and Systems team to identify and mitigate cross-GXP supplier related quality and compliance issues

· Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution

· Lead process improvement initiatives as requested by management

· Provide professional expertise and strong leadership in GCP guidance and regulations, proactively identifying potential areas of non-compliance and risk.

· Participate in GCP health authority inspections, as required

· Mentor and provide support to Manager level CQA personnel, as needed

· May act as supervisor for temporary contractors

EDUCATION & Behavioral Skills:

· BA/BS degree required; Advanced Degree preferred.

· Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.

· Experience in Quality assurance.

· Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development.

· Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.

· Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems.

·Strong technical writing skills; able to write quality positions, audit reports, and procedures.

· Excellent communication skills with ability to negotiate and influence without authority in a matrix environment.

·Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines.

· Superior attention to detail and ability to analyse complex data.

Licenses / Certifications:

GCP Quality Assurance registration/certification preferred.

Travel:

· Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.

Requires approximately 30%

Job Types: Full-time, Contract

Pay: $130.00 - $150.00 per hour

Expected hours: 40 per week

Schedule:

• Monday to Friday

Shift availability:

• Day Shift (Preferred)

Ability to Commute:

• Cambridge, MA 02138 (Required)

Ability to Relocate:

• Cambridge, MA 02138: Relocate before starting work (Required)

Work Location: In person

Salary : $130 - $150