Job Information
Boehringer Ingelheim AD, GI Site Quality in North Brunswick, New Jersey
Short Description
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Description
Global Innovations (GI) represents the Animal Health Research and Development team at Boehringer Ingelheim.
Set framework for Quality Management Systems to assure compliance with local GxP regulations as well as BI requirements applicable for the assigned site. This position manages the overall inspection readiness, leads inspections and ensures the conformity with the relevant GxP requirements. The incumbent is responsible for implementation and execution of Corporate BI Quality procedures and processes that are applicable for the site's scope and purpose.
The position is in charge of coaching, encouraging and supporting site personnel (within Quality and GI) as well as site leaders to create an environment of teamwork and innovation.
As leader of Quality, he/she is in charge to drive culture, transparently communicate, and inspire others to implement a mindset of quality ownership by everyone.
Duties & Responsibilities
Drive the overall quality for the site regarding Quality projects, New Product Development, and Technology Transfers including serving as the primary interfaces with Regulatory Affairs and associated Regulatory Agencies.
Be part of the local site leadership team.
Compliance: Implementation, maintenance and enhancement of quality procedures and systems to ensure compliance with internal and external GxP requirements. Drive the Quality Management Review and the quality plan of the site.
Inspection and Audit Management: Management of regulatory inspections and corporate audits, including management of the most appropriate action plan to address the findings pointed out by the investigators/auditors. Raise potential findings observed at site that might be of relevance for other GI sites to the Regional Quality Head or other leadership team members.
Provide appropriate training and support for the preparation and realization of inspections at the site.
Continuous Improvement : Drive the Continuous Improvements using advanced data management techniques and quality methods / tools including appropriate metrics to monitor progress. Promote innovation, best practices and system performance.
Management of the local SOP landscape.
Keeping the site-related master schedule updated regarding all relevant studies.
Quality Support to GI projects :Ensure appropriate quality oversight, quality guidance and input as well as overall support for GI projects.
Plan and manage local audit and inspection of study related activities (protocol, critical phase inspection or Investigator site inspections, raw data, report) - third parties for local suppliers
Quality Risk Management (QRM) : Oversee QRM process at the site in order to foster early risk identification, appropriate risk assessment and to define appropriate action plans to mitigate critical risks.
Quality Representative: Provide input for needs/specificities/feasibility for the site regarding relevant global Quality projects/discussions (e.g. new Quality project initiatives, MSO concept rollout, data integrity, etc.) unless a local SME/contact is defined.
Serves as Site GI Quality representative for US GIQA budget and forecast discussion.
Requirements
Masters degree (e.g. MBA, MSc) and/or Diploma Degree and/or Doctoral Degree (e.g. PhD, MD) with major focus on Biology, Chemistry, Pharmaceutics, Veterinary or Quality Management or equivalent education and experience.
Minimum of 8 years experience in Quality roles
Strong experience with regulatory inspections and regulations as well as GxP requirements as applied to the site.
Ability to make clear decisions, appropriately balancing risks versus consequences
Strong leadership skills with the ability to get the buy-in of multiple stakeholders.
Ability to work under pressure, cope with multiple priorities and deal with ambiguity.
Proactive and motivated with a clear passion to drive change and make significant improvements.
Leadership skills including: Inspiring, Coaching, Empowering, project/time management
Strong oral and written communication skills as well as interpersonal skills (resource planning, conflict management, open-mindness, networking).
Ability to work in a team and matrix environment and network across the company as well as to position QA as a pragmatic and reliable partner for GI.
Eligibility Requirements:
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.