Boehringer Ingelheim Group Leader, Quality Systems in SAINT JOSEPH, Missouri
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
This individual will be responsible for maintaining compliance in the area of Documentation control and Quality Systems. Provide direction and supervision in the Document Control area with respect to documentation management, archival, and issuance according to company policies and corporate business plans. Develop, maintain and administer adequate training for reports. Be an SME in the area of IDEA for CON and issuance of production records. Assist maintaining inspection ready room during regulatory or corporate audits. Identify process improvements and necessary resources for day to day activities. Serve as backup or deputy to manager in their absence.
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 a number of 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.
Duties & Responsibilities
Maintenance and timely issuance of production records to different product groups as to not delay production. Oversee and ensure compliance to the document archival.
Oversee controlled document management through a combination of IDEA for CON and paper systems. This individual will draft, review and approve relevant SOPs, Controlled Forms and other documents to implement revisions resulting from revision to regulatory requirements, change controls and company driven changes. This person will, also, conduct training as required for maintaining excellence in the Documentation revision process.
Review and approval of Standard Operating Procedures/Controlled forms to assure compliance with all pertinent regulations (APHIS, EU, FDA)
Improve productivity of the group. Optimize resources.
Set STAR goals (MAG Plan) for reports. Mentor and develop reports and manage talent
Assist with regulatory and corporate inspections and help maintain the inspection ready room and pull necessary documents for the inspection.
Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management.
Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI’s excellent reputation in the community.
Minimum of a Bachelor’s degree, from an accredited institution, with eight plus (8+) years of business experience or a Master's degree, from an accredited institution, in a relevant scientific field with six plus (6+) years of relevant business experience or a PhD, from an accredited institution, in a relevant scientific discipline with three plus (3+) years of relevant experience.
Four (4) to six (6) years project management experience
Good written and verbal communication skills coaching, organization and teamwork skills.
Demonstrated leadership ability and aptitude to train and utilize workers in a multi-faceted environments.
Has sound decision making skills along with ability to take quick actions.
Work experience in USDA, European Union (EU) and/or FDA regulated animal health industry required.
This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source, TrackWise and other relevant electronic applications.
Influencing the understanding of GMP's, compliance requirements, and regulatory requirements to assess product, procedures, and recommended improvements to make quality decisions
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
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA,Boehringer Ingelheim Vetmedica Inc. and Boehringer Ingelheim Fremont, Inc. is an equal opportunity employer. Minority/Female/Protected Veteran/Person with a Disability
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
Title: Group Leader, Quality Systems
Location: Americas-US-MO-Saint Joseph
Requisition ID: 1815561