▷ (15h Left) Sr. Manager, QA Compliance DRP
2 days ago
At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives.
JOB SUMMARY:
The Sr. Manager QA Compliance is responsible for managing and leading improvements for GxP Quality Management System. This role ensures GxP activities are completed in alignment with Regulatory requirements, industry best practice and company procedures. The role will lead continuous improvement initiatives for key GxP processes. The role will also be the Deputy Responsible Person (DRP) for Ireland. This role interacts with multiple functions within BioCryst, e.g. QA, Supply Chain, Finance, Regulatory, Pharmacovigilance, Information Technology, Pharmaceutical Development, QC and Clinical. #LI-REMOTE
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Lead continuous improvement initiatives for BioCryst Quality Management Systems and authoring key GxP procedures.
- Lead compliance initiatives across GxP functions, driving a quality culture and on-time closure of quality system records.
- Ensure an internal audit program is implemented and maintained and self-inspections are performed as scheduled.
- Coordinate Quality Management Review and associated process including management of Global GxP Quality Metrics.
- Act as the DRP on the BioCryst Ireland WDA ensuring the conditions of the license are met.
- Ensure global corporate procedures and standards are implemented within the local and regional QMS and in alignment with Quality and Business strategies.
- Support the preparation, implementation and ongoing maintenance of the local Quality Management Systems (QMS) for GMP/GDP activities supporting regulatory requirements and local standards.
- Support Health Authority Inspections and inspection readiness programmes.
- Support regulatory intelligence initiatives.
- Ensure internal quality agreements are implemented and maintained.
- Maintain the BioCryst Quality Manual.
- Ensure all compliance issues are tracked, managed, and escalated to Management as appropriate.
- Ensure a system is in place for the maintenance of cGMP/cGDP licenses (e.g. WDA, etc) to support business operations compliance.
- Provide support and contribute to other Quality Assurance activities as assigned.
EXPERIENCE & QUALIFICATIONS:
- Minimum of a BS Degree in sciences or equivalent required.
- Minimum of ten (10) years of pharmaceutical experience in QA Operations, Manufacturing, QC and/or other relevant operational areas required, experience in GDP an advantage.
- Experience supporting regulatory authority inspections and interfacing with regulatory authorities preferred.
- Extensive knowledge of EU GDP and HPRA guidelines.
- Knowledge of US, EU, ICH Regulations, guidelines and requirements.
- Strong understanding and ability to implement risk management fundamentals/tools.
- Excellent technical writing skills.
- Experience in continuous improvement projects.
- Excellent communication, problem-solving and decision-making skills.
- Excellent organizational skills and ability to work on multiple projects with competitive timelines.
- Strong attention to detail and respect for the need of accuracy of information.
- Must be capable and willing to travel (up to 15%), including the potential for international travel.
- Advanced software skills (e.g., Microsoft Excel, PowerPoint, Microsoft Project).
- Demonstrated ability to work effectively in a cross-functional team environment and independently in a remote work setting, as necessary.
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.
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