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.

Compensation Data: This position offers a base salary typically between $72,000 and $152,000 annually. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.

Description

Works independently to provide leadership and oversight to junior QA team members as they provide QA oversight of any area of the business responsible for adhering to current Good Manufacturing Practices (cGMPs) including critical utilities, (e.g. WFI, Steam, Automation, equipment, HVAC, etc.), warehouse, manufacturing processes, inspection, labeling and packaging, batch record review, batch disposition, new product introduction/product transfer, external quality and laboratories. Utilizing a wealth of previous experience, provides a high level of independent judgment and discretion in the timely identification, investigation and resolution of events impacting the Quality of products and processes. Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA)/Deviation management, impact assessments for changes to equipment and processes, risk management, and to ensure documentation and investigations meet BIFI and regulatory standards. With autonomy and authority, makes difficult decisions with little time for deliberation which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas. Responsible for mentoring, coaching, may act as a delegate to sign official documentation in the place of management, and makes difficult decisions with little time for deliberation that can have a direct impact on active manufacturing operations, the release of equipment or area, or product release. Implements continuous improvement efforts as it relates to QA activities. Indirectly leads others within the QA Team under the leadership of the area head. Fosters quality collaboration among the site and QA staff. 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

Requirements for a Sr. Specialist QA

Requires a Bachelor's or higher degree from an accredited institution preferably in sciences.
Requires a minimum of five (5) years of experience working in the Quality aspects of a life sciences or closely related industry.
Requires a minimum of one (1) year of experience managing projects and priorities within complex matrix organizations.
Must have demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
Strong independent judgment and decision making abilities required.
Experience leading people and/or projects with history of achieving results and outstanding outcomes.
Advanced knowledge of relevant regulations and guidances required in order to act as a resource for colleagues.
Proven project-management skills required. Must be able to manage multiple projects against given time-lines.
Demonstrated hard-working and productive work ethic in an ambiguous environment strongly preferred.
Independent decision making capability and ability to think conceptually and understand impact of decisions critical
Proven global problem-detection and problem-resolution skills required
Possesses strong conflict resolution and negotiation skills
Must be able to independently represent the department in a wide-assortment of situations
Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
Must possess excellent verbal and written communication skills; good interpersonal skills.
Must have experience ensuring respectful interactions with individuals with diverse views or backgrounds.
Emerging leadership and mentoring experience required. Must be able to indirectly lead others on the assigned floor / shift in the absence of the department head.
Ability to work independently.
Physical Demands / Surroundings - The duties of this position may require the incumbent to exert some physical effort. Lifting requirements may vary dependent of the QA area assigned. Weight is typically no more than 25 pounds. Work environment is dependent upon the area assigned. For example, Manufacturing Operations QA requires full gowning and gloving certification, ILP will require inspection validation requirements are met, lab-based areas will require bench training and that laboratory protocols and dress code are adhered to.
Visual Demands - Must be able to read and see clearly. Employees assigned to ILP will be required to participate and have acceptable results from vision testing including color-blindness.
Temperaments/Mental Requirements - Frequently required to exercise judgement and make decisions. Probable errors might cause moderately serious delays, confusion, and could affect company reputation/customer relations or expense to correct.
Attendance / Schedule - Attendance requirements are based on BIFI general attendance policies.

Requirements for Specialist QA

*   Requires a Bachelor's Degree from an accredited institution preferably in sciences plus minimum of three (3) years of experience working in the Quality related aspects of a life sciences or closely related industry.
*   In lieu of a Bachelor's Degree, a High School Diploma plus seven (7) years of experience working in the Quality related aspects of a life sciences or closely related industry will be considered.
*   Mentoring experience required.
*   Strong independent judgment and decision making abilities required.
*   Strong knowledge of relevant regulatory guidances.
*   Demonstrated problem-detection and problem-resolution skills required.
*   Strong conflict resolution and negotiation skills required.
*   Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
*   Must possess excellent verbal and written communication skills; good interpersonal skills.
*   Capability to establish good relationships with others who have different values, cultural styles and perspectives.
*   Setting high and ambitious goals and standards for oneself and others, continuously raises the bar.
*   Physical Demands / Surroundings - The duties of this position may require the incumbent to exert some physical effort. Lifting requirements may vary dependent of the QA area assigned. Weight is typically no more than 25 pounds. Work environment is dependent upon the area assigned. For example, Manufacturing Operations QA requires full gowning and gloving certification, ILP will require inspection validation requirements are met, lab-based areas will require bench training and that laboratory protocols and dress code are adhered to.