- Our company is a leading global provider of in vitro diagnostics.
- We have an established track record for providing high-quality products and services to the global clinical laboratory and immunohematology communities.
- Our company has approximately 3,800 employees, serving customers in more than 120 countries.
- We are recruiting and retaining the best and brightest around the world.
- People who are performance driven, want to make a difference and who help us grow our leadership position in a changing marketplace.
- The power to re imagine starts with empowered people.
- People who are empowered to grow and given the chance to succeed in ways they hadn’t thought possible before.
- Our purpose is simple: to improve and save lives with diagnostics.
- We do that by re imagining what’s possible. It’s what defines us.
The Career Potential:
- Our company is committed to improving and saving lives with diagnostics.
- To do this we hire people who share this dream and are ready for new adventures.
- As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before.
- There is no limit to the experiences, opportunities and new directions you will have access to here at our company.
- More importantly, you will be driving the surge of a whole new direction in important medicine.
- That’s something we can all take pride in as we take this journey together.
- The Global Compliance Manager will be a key and strategic member of the Global Compliance team.
- In this capacity the Global Compliance Manager will be responsible for global regulatory inspection readiness activities for manufacturing sites and global business functions within the organization.
- He/she will serve as lead for assigned inspection readiness activities in order to assure each area is able to successfully demonstrate compliance during regulatory inspections.
- This role will liaise with global partners in order to share information and updates for his/her responsible area in order to assure visibility and consistency across the organization. The Global Compliance Manager will be the leader for the inspection readiness program and expert in global inspection requirements.
- Responsible for coordinating global regulatory inspections at company sites, including the preparation activities, overall management strategy and logistics prior to and post inspection (End-to-End inspection coordination). Inspection readiness lead for assigned manufacturing sites.
- Lead regular inspection preparation and readiness meetings in order to develop strategy and risks, identify and prepare subject matter experts and inspection staff. Work closely with site manufacturing lead and key relevant staff.
- Compliance and Inspection readiness lead for multiple company global processes, as assigned, working with business process owners and Quality leads to ensure Quality Systems and relevant business processes are audit ready.
- Perform regular process and data reviews to assure inspection adequacy and preparation and identify and escalate as required areas requiring focused attention.
- Lead inspection response writing activities; to lead team in preparation of responses, filing response within required timelines, tracking and management of commitments to assure timely and adequate follow-up of activities.
- Conduct internal audits, as assigned.
- Minimum of a Bachelor’s degree in Science, Engineering, QA or other related business field or equivalent job experience.
- A minimum of 8-10 years’ experience related to compliance processes in a regulated biologics, pharmaceutical and/or medical device environment is required with a preference for a background in the in vitro diagnostics (IVD) industry.
- Expert knowledge in quality compliance, and previous experience in global internal/external audits.
- Must have experience directly supporting audits and Front room audit hosting experience preferred.
- Ability to work with limited supervision, superior attention to detail, excellent grammar and proofreading skills.
- Proven multi-tasking ability.
- Strong interpersonal and communication skills.
- Able to maintain a high degree of confidentiality and professionalism and be able to successfully interact with individuals at all levels of the company.
- Up to 15% domestic and/or international travel.
- This role will interact with multiple global functions within the company to provide strategic input and direction for Compliance; including Managers and Directors from Quality, Operations, R&D, and Commercial as well as subject matter experts at various levels in the organization.
- Must be able to coordinate with and influence internal business partners.
- Must be able to collaborate with and influence external global regulatory bodies to support audits.
- We are proud of the empowering, inclusive and innovative culture we are growing.
- Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making company a place to grow your career. Our company is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law.