Boehringer Ingelheim Team Leader/Group Leader, QA Release 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.

Description:

The basic purpose of this position is to provide technical direction and supervision in the QA Release department according to company policies and corporate business plans, to provide technical competence through proper selection and training the work force, assure QA Release functions are performed according to current regulatory requirements and company policies, maintains area of responsibility within budget guidelines and serves as a backup to the Associate Director, QA Release or direct supervisor in the event of 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

  • Documentation Review/Approvals :

  • Resolves major issues that are not defined by SOP.

  • Performs review and approvals of MBPS/CBRs/international permits for international releases.

  • Performs documentation review of media fills and media fill protocol approvals as needed.

  • Change Control:

  • Performs review and approvals of change controls as a subject matter expert (SME) in QA Release for routine change controls.

  • Performs review and approvals of significant change controls (new facility/new equipment/new product).

  • Completes change control action items as assigned.

  • Revises existing procedures as changes occur.

  • Creates new documents (SOPs/Forms/templates) as needed.

  • Deviations/CAPA:

  • Initiates deviations in Quality electronic systems when non-conformances are detected during documentation review.

  • Assesses reviews and approves deviations (dept approver) and assigns investigations as needed.

  • Writes or participates in deviation investigations for determination of appropriate root causes.

  • Serves as QA approver for investigations as needed.

  • Performs follow-up on CAPAs for completion for self as well as direct reports. Ensures CAPA extensions are requested prior to due dates as needed.

  • SAP :

  • Performs movement transactions in SAP system of product as needed.

  • Performs usage decisions for batch release in SAP

  • Performs second check in SAP prior to batch release.

  • Performs conditional usage approvals as needed.

  • Serves as a key user for SAP in the resolution of system or set up issues.

  • Performs assessment and approvals of requests for items that are returned to stock.

  • Projects :

  • Actively participates on project teams as assigned by supervisor

  • Coordinates and leads projects within group without supervision.

  • Coordinates and leads projects including other departments/groups.

  • Serves as department SME on cross functional groups.

  • Training :

  • Completes all assigned training by target due dates as assigned by BIVI.

  • Completes on the job training for each assigned job task.

  • Cross trains on other job tasks within department.

  • Assists with training other individuals within the department on specific tasks.

  • Performs training other individuals within department per assigned training plans.

  • Assists QA management with the development of training plans within department and trains others.

  • Develops training plans and trains others, including training outside of area of responsibility.

  • Develops and maintains training curricula within areas of responsibility.

  • Regulatory :

  • Demonstrates understanding of regulations for various countries.

  • Routinely reviews regulatory correspondence/audit reports and assures compliance of QA Release procedures.

  • Provides input into regulatory filings (OOPs/dossiers).

  • Provides approvals for non-routine testing/samples

  • Generates information/data for possible market actions.

  • Reviews and performs approvals for reprocessing activities for non-conforming serials.

  • Actively participates in external groups (PTEA, AHI)

  • Management :

  • Manages expenses within department.

  • Develops direct reports through performance management systems (MAG/Development plans) on an annual basis.

  • Manages resources/staffing within areas of responsibility.

  • Identifies and purchases equipment/tools needed for QA Release dept.

  • Audits/Inspections:

  • Participates in internal audits as assigned by management.

  • Participates in 3rd party audits as assigned by management.

  • Serves as an SME for strategy rooms during internal and external audits/inspections.

  • Identifies, creates CAPAs and tracks them through to completion.

Team Leader Requirements:

  • Bachelor’s degree, from an accredited institution, in a relevant scientific discipline plus five (5) years of relevant experience OR Master’s degree, from an accredited institution, in a relevant scientific discipline plus three (3) years relevant experience OR PhD from an accredited institution in a relevant scientific discipline is required for this position.

  • NOTE : Relevant BIVI experience may be weighted more significantly.

  • Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI’s excellent reputation in the community.

  • This position requires the ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source and other relevant electronic applications.

  • A basic understanding of GMPs, Outlines of Production, 9 CFR and compliance requirements is required for this position in order to properly assess product, procedures, recommend/drive improvements and make correct decisions.

Group Leader Requirements:

  • Bachelor’s degree, from an accredited institution, in a relevant scientific discipline plus eight (8) years of relevant experience OR Master’s degree, from an accredited institution, in a relevant scientific discipline plus six (6) years relevant experience OR PhD, from an accredited institution, in a relevant scientific discipline plus three (3) years relevant experience is required for this position.

  • NOTE : Relevant BIVI experience may be weighted more significantly.

  • One (1) to three (3) years leadership and project management experience

  • Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI’s excellent reputation in the community.

  • This position requires the ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source and other relevant electronic applications.

  • A basic understanding of GMPs, Outlines of Production, and 9 CFR and compliance requirements is required for this position in order to properly assess product, procedures, recommend/drive improvements and make correct decisions.

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

Our Culture:

Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. 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. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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 verifications and drug screenings.

Organization: US-Vetmedica

Title: Team Leader/Group Leader, QA Release

Location: Americas-United States-MO-Saint Joseph

Requisition ID: 1810522