O pracovní pozici
We are seeking a highly motivated Quality leader who is interested in joining our fast-paced, dynamic startup environment. The Compliance Manager is responsible for activities related to Quality Management System (QMS) oversight, audit, and inspection follow up (CAPA) and will support readiness activities. Coordinating closely with Quality members, this position provides expertise and support in all continuous improvement activities. This position will also partner with key internal business stakeholders and will work cross functionally on continuous improvement activities to drive effective, compliant, and sustainable solutions/ outcomes. Incumbent will apply quality management and continuous improvement theory, technical principles, and expert judgment to proactively assist the business in the identification of potential risks and lead activities to ensure mitigation and improve 503B compliance and enhance performance of key 503B activities. Core to these activities will be the ability to effectively manage projects and foster effective interdepartmental and cross-functional partnerships.
- Lead projects that impact the Quality Management System. Report on progress against schedules, milestones and project goals, evaluate project resource needs and availability, identify and report gaps or project constraints, and develop solutions for successful implementation.
- Enforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles. Support all regulatory and customer quality audits.
- Manage direct reports – Lead and coach team driving a high performance organizational culture.
- Gather, organize & analyze data to develop solutions & alternative methods of proceeding; execute continuous improvement projects to optimize operations to deliver process improvements
- Assist CAPA teams, and other project teams, in the development of action plans and implementation schedules, and the verification of completed actions.
- Identify compliance issues that require follow-up or investigation.
- Conduct or direct the internal investigation of compliance issues.
- Conduct or direct the internal investigation of customer complaints.
- Track compliance issues within all departments and ensure completion within defined timelines.
- Assess product, compliance, or operational risks and develop risk management strategies.
- Disseminate written policies and procedures related to compliance activities.
- File appropriate compliance reports with regulatory agencies.
- Evaluate testing procedures to meet the specifications of environmental monitoring programs.
- Verify that software technology is in place to adequately provide oversight and monitoring in all required areas.
- Maintain documentation of compliance activities, such as investigation outcomes.
- Consult with corporate attorneys as necessary to address difficult legal compliance issues.
- Discuss emerging compliance issues with management or employees.
- Advise internal management or business partners on the implementation or operation of compliance programs.
- Provide assistance to internal or external auditors in compliance reviews.
- Prepare management reports regarding compliance operations and progress.
- Monitor compliance systems to ensure their effectiveness. Oversee internal reporting systems such as corporate compliance hotlines and inform employees about these systems.
- Develop or implement environmental compliance plans for programs, such as air, surface and personnel sampling.
Vystupte z davu
You possess the following qualifications, background and abilities:
- BS/BA degree with 5 years of pharmaceutical industry experience in quality assurance/quality control or an equivalent combination of education and experience in a scientific or health-rated field
- Minimum 2 years directly related experience supporting compliance in a quality/compliance function /applicable compliance field.
- Knowledge of QMS and CAPA related tools or systems is required.
- Environmental monitoring or audit experience is an asset
- Experience with health authority inspections and inspection readiness activities preferred.
- Strong personal leadership with demonstrated competency interfacing with senior leaders is required
- Working knowledge of applicable US FDA, USP and state board regulatory requirements and guidelines as applicable to the pharmaceutical industry.
- Excellent communication skills:
- Listening, interpreting and summarizing information
- Clear and concise verbal communication
- Professional and concise written communications –exceptional attention to detail
- Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.
- Strong interpersonal skills and the ability to assist personnel in a matrix organization, ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
- Highly ethical, self-motivated and self-directed; works effectively independently as well as in a team environment.
- Strong project management skills: MS Word, Excel, PowerPoint,
- Flexible and able to adapt to company growth and evolving responsibilities.
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.