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.

The Senior Supervisor, Quality Control is responsible for the safe and efficient operation of the Quality Control (QC) Operation groups that include Chemical and Microbiology laboratories and Incoming sampling area. This role will ensure that QC group operates according to company policies, and regulatory requirements (GLPs, cGMPs and EU regulations, etc.) in alignment with business plan. The incumbent ensures proper prioritization and planning of the tasks and activities assigned to the QC personnel to meet commitments and achieve goals. This role will foster collaboration and partnership among Quality and other areas.

The SR Supervisor, QC provides technical competence of QC group through selection, training and development of personnel. The incumbent drives and promotes a self-management teams as a way of working focus in continuous improvement. This role leads and promotes the implementation of new technologies while maintaining compliance and efficient QC processes.

Duties & Responsibilities

• Assures proper planning and prioritization of raw materials/packaging components sampling and testing in alignment with schedules and business needs.

• Responsible for timely and efficient chemical and microbiology testing for raw materials, in-process, finished goods, cleaning, stability and/or special requests.

• Maintains contact with other departments, such as Production, Planning, Warehouse to assure achieve product supply.

• Ensures the proper administration of the Stability Program including evaluation of trends/testing at appropriate intervals as per NADA/Regulatory commitments.

• Determines technical adequacy of the scientific documents and testing methods used within Quality Control departments. Assure continuous revision of the testing requirements (e.g., pharmacopoeias) to maintain updated the QS, analytical reports, sampling, LIMS, SAP master data among other documents.

• Coordinates the maintenance and/or maintains adequate supplies of test solutions, reference standards, reagents chemicals and spare equipment by requesting items in advance.

• Responsible for the timely investigation of any event or discrepancy.

• Provides direction and facilitates the process with coordination of RCA activities, participation in discussion, identification of resources, involvement of the necessary areas etc.

• Works as investigator is necessary.

• Responsible for the selection and qualification of contracted laboratories (if applicable).

• Activities are (but not limited to) prepare justification, selection, audit, method transfer etc.

• Coordinates all activities related to the transfer of new products into QC.

• Works with the QC group to develop an efficient and compliance strategy. This should include (but not limited) identification of equipment, reagents, resources, capacity and lead times etc.

• Supports the site in technology transfers of new products.

• Provides guidance ensuring robust and compliances processes involving QC, manufacturing, QA, or other topics.

• Supports the allocation of the department budget for Quality Control.

• Monitors spending to stay within prescribed limits and proposes and develop new budget information.

• Identifies and explores new ways for savings to improve spending.

• Provides strong oversight of data integrity with instrumentation and manual processes used throughout the QC group.

• Supports completion of Change Control documents.

• Participates in the revision and approval of installation and qualification protocols for laboratory instruments, as required.

Requirements

• Bachelor's degree in microbiology, chemistry or related scientific area.

• Between four to five (4-5) years relevant industry experience in a GMP in pharmaceutical production environment.

• Minimum of two to three (2-3) years in a laboratory management environment leading people.

• Strong understanding of external regulations e.g., FDA, EMEA, ICH and others.

• Must demonstrate ability to work and communicate with diverse groups across the organization at managerial levels and below on a routine basis.

• Must have strong technical background with experience handling internal/external audits and regulatory agencies.

• Strong negotiation and influencing skills with the ability to drive results.

• Excellent interpersonal skills.

• Excellent problem solving and decision-making skills.

• Excellent communication skills, both verbal and written, in English and Spanish.

• Ability to read, understand and interpret policies, regulations, guidelines and procedures.

• Excellent analytical skills.

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.

Desired Skills, Experience and Abilities

Additional Duties & Responsibilities:

• Assures compliance with industry guidelines and regulations.

• Maintains the QC areas always prepared for audits and inspections.

• Hosts inspections and audits of the QC areas.

• Manages a consistent response to all previous regulatory and internal cGMP’s observations related to the QC areas.

• Assures timely completion of the actions.

• Provides technical competence of Quality Control areas through selection, training and development of staff, ensuring a safe and stable workforce.

• Immediately reports to management any violation noted/observed to regulations and company policy and procedures.

• Demonstrated high ethical and professional standards with all business contacts.

• Drives the continuous improvement of process, systems and culture in the organization.

• Models behaviors aligned with the site continuous improvement mindset.

• Challenges the status quo.

• Implements ideas, programs and initiatives that will have sustainable long-term benefits according to the organization strategic goals and objectives.

• Drives Environmental, Health and Safety (EHS) compliance in the organization.

• Actively engages and role models behaviors aligned with the site EHS philosophy and assures full on-time compliance with applicable EHS training programs and requirements.

• Empowers, motivates and drives people development.

• Assures annual performance review activities be conducted on time.

• Promotes and engages with direct reports by conducting frequent 1:1’s to discuss career development opportunities, support annual TDD activities and assure individual development plans are up to date and aligned with site priorities and strategic business needs.

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.