Quality Compliance Lead

le contenu du travail

Quality Compliance Lead – Penzberg, Germany

The Quality Compliance Lead/Specialist is responsible for implementing and assuring a phase appropriate GLP/GCP Quality Management System (QMS), ensuring it is simple, robust, inspection ready, maintained in a state of control and in compliance with internal and applicable EU (EMA) and US (FDA) GLP/GCP regulations.

Activities and Responsibilities

· Provide QA oversight, technical QA expertise, support and leadership across the Pre-Clinical and Clinical Operations.

· Assure the compliance of clinical operations and preclinical quality systems

· Operate closely with clinical and pre-clinical teams

· Utilize audit and inspection intelligence and risk mitigation plans to assure adherence to GCPs in the conduct of clinical trials, the quality and integrity of generated data and welfare and rights of subject safety

· Act as QA GLP/GCP representative during Regulatory Inspections and 3rd party audits

· Lead and perform audits including audits of clinical investigator sites, third parties, clinical trial master files, contributing scientist reports, clinical summary reports, and final reports, supporting operations related to GCP, GPvP, GCLP, and GLP

· Manage the clinical and preclinical operations internal and external audit programme

· Responsible for analysis and reporting of clinical quality KPI and data to identify potential trends and risks and producing matrices to support the senior leadership.

· Operate globally to assure clinical studies are performed to all local regulatory requirements

· Operate in alignment with the QMS lead and other QA teams to assure interfaces are maintained

· Provide GCP/GLP training to staff

· Maintain an awareness and thorough understanding of new GCP/GLP regulatory requirements and assure the QMS incorporates these as required in timely fashion

· In partnership with clinical and preclinical operations, provide quality oversight of internal and external clinical and preclinical activities

· Collaborate with clinical and preclinical functions to ensure compliance with all applicable regulations and standards

· Act as a technical resource to resolve GCP/GLP issues based on knowledge of regulations, guidelines, and relevant SOPs

Job Description

· Proactively identify quality issues/discrepancies; communicate, and effectively resolve issues in collaboration with internal and external partners

· Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures

· Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken

· Responsible for ensuring that any GMP documentation, issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state

Key Job Competencies

· GCP/GLP quality systems development, implementation, and management

· Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to compliment data; Designs workflows and procedures.

· Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyses information skilfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.

· Change Management - Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.

· Cost Consciousness - works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organisational resources.

· Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence

· Planning/Organising - prioritises and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organises or schedules other people and their tasks; develops realistic action plans.

· Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.

· Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.

· Innovation - displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.

· Oral Communication - speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.

· Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.

· An excellent level of English is a prerequisite for this role, German would be a distinct advantage

Job Background

Master’s degree in life science or equivalent

Strong and demonstrable track record of GCP and GLP auditing experience of Early and Late Phase clinical trials within Pharma

Experience hosting sponsor audits and regulatory inspections

Experience leading GCP inspection readiness activities

Demonstrable experience in a quality management systems position in the pharmaceutical or other regulated industry

Proficiency in a body of information required for the job e.g. knowledge of EU, FDA and global regulations, for GCP, GLP, GPvP, and GCLP

High degree of flexibility and ability to adjust to changing priorities