Manager, QC

Jobs2Web; Barceloneta (PR); Sur place; USD 110 000 - 170 000; Plein temps

Résumé du poste

Boehringer Ingelheim in the United States seeks a Manager, Quality Control to lead the QC Laboratory and Incoming Samples operations. You will drive compliance with cGMPs, GLPs, and regulatory commitments while mentoring a skilled team to ensure timely testing and data integrity.

As site SME, you will coordinate with production, implement continuous improvement, prepare budgets, and act as primary contact during inspections and audits.

Qualifications

• Bachelor's degree in microbiology, chemistry or related field; 7–8 years in GMP pharmaceutical labs.
• Minimum 5 years in a laboratory management role leading a substantial number of employees.
• Strong knowledge of FDA, EMEA, ICH regulations and GMP practices.
• Excellent organizational, supervisory, and leadership skills to manage a team and technical staff.
• Technical English and Spanish, oral and written communication.

Responsabilités

• Provides direction, delegates and removes obstacles to assure completion of QC sampling and testing.
• Plans and prioritizes to meet business commitments aligned with organizational goals.
• Maintains proper reagent inventory and equipment spare parts; ensures schedules are met.
• Oversees QC testing and incoming sampling against required timelines.
• Leads the change control process and ensures regulatory and quality documentation is compliant.

Connaissances

Laboratory management

Regulatory knowledge

Leadership

Technical English

Spanish language

Formation

Bachelor's degree in microbiology or related field

Master's or PhD preferred

Description du poste

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, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Manger, Quality Control will manage and provide direction within the Quality Control Laboratory and Incoming Samples areas. The position holder will handle all matters concerning the compliance of QC assuring that all processes and documentation meet cGMPs, GLPs, regulations and quality policies. The incumbent will work independently, having a thorough knowledge of plant operations, and ability to communicate to all levels of management. This role will lead and direct the staff that performs the sampling, chemical and microbiology testing promoting a self-managed organization.

The Manager, QC will provide technical oversight to the QC team to assure proper and prompt resolution of situations that could impact product efficacy, purity and safety. This role will maintain close communication with production and functional areas to pursue proper coordination of the QC activities and avoid business interruptions. The incumbent will act as site Subject Matter Expert (SME) in QC technical aspects as well as maintain a continuous improvement philosophy leading innovation and challenging the status quo.

Duties & Responsibilities

• Provides direction, delegates and removes obstacles to assure completion of QC sampling and testing.
• Plans and prioritize to meet business commitments aligned with organizational goals.
• Facilitates the activities assuring proper reagent inventory, and equipment spare parts etc.
• Maintains close communication with production and functional areas to assure QC testing and incoming sampling meet required schedules.
• Oversees and strategically supports the proper administration of the Stability Program including evaluation of trends/testing at appropriate intervals as per NADA/Regulatory commitments.
• Strategically works with QC Supervisors to assure technical adequacy of the scientific documents and testing methods used within Quality Control departments.
• Provides technical expertise and guidance during investigations of events or deviations. Coordinates and/or conducts the investigation if necessarily.
• Leads innovation based on area needs and opportunities for new technology to optimize processes maintaining compliance posture.
• Develops strategy, leads and works in coordination with GMSAT and LMSAT transfer of new products into QC.
• Supports site transfers through strategic leadership and direction ensuring robust processes and compliance.
• Participates in meetings as SME to provide input or support for manufacturing, quality, or other topics.
• Revises, provides impact assessments and approves Change Control documents as QC SME.
• Prepares and allocates the department budget for Quality Control.
• Monitors spending and proactively identify any negative trends and explore actions to avoid it.
• Identifies and explores new ways for savings to improve spending.
• Provides strategic direction on general data integrity compliance in all areas within QC.
• Works with QC team to determine area needs and opportunities.
• Facilitates the acquisition, installation and qualification for new laboratory instruments and Incoming area equipment, as required.
• Assures laboratories and Incoming areas maintain continuous Inspection readiness.
• Responsible for compliance with industry guidelines and regulations.
• Primary contact during an inspections and audits of the QC areas.
• Directs and assures responses to all previous regulatory and internal cGMP's observations related to the QC areas are done in a consistent and compliant fashion.
• Empowers, motivates and drives people development.
• Assures timely completion of annual performance review activities.
• Promotes and engages with direct reports by conducting frequent 1:1's to discuss career development opportunities, supports annual TDD activities and assures individual development plans are up to date and aligned with site priorities and strategic business needs.
• Role models highest ethical and professional standards performing all Company business in accordance with all regulations (e.g., FDA, EMEA, HC, etc.) and Company policy and procedures.
• Immediately escalates as appropriate, any violations to regulations.
• Leads and models a culture of quality and continuous improvement in the organization.
• Drives an improvement mindset, implement ideas, programs and change management initiatives that will have sustainable long-term benefits according to the organization strategic goals and objectives.
• Assures overall compliance with all environmental guidelines, procedures, training, practices, permit conditions, and internal notification of any environmental events within the QC area.
• 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.

Requirements

• Bachelor's degree in microbiology, chemistry or related scientific area and between seven to eight (7-8) years of relevant industry experience in a GMP in pharmaceutical production environment; Master or PHD degree is preferred.
• Minimum of five (5) years in a laboratory management environment leading a substantial number of employees.
• Strong understanding of external regulations e.g., FDA, EMEA, ICH and others.
• Demonstrates ability to work and communicate with diverse groups across the organization at managerial levels and below on a routine basis.
• Excellent organizational, supervisory, and leadership skills to manage a team and technical staff.
• Technical English and Spanish, oral and written communication.
• Leadership skills, including but not limited to delegation, motivation, influencing, conflict management, teamwork, and negotiation.
• Problem solving and decision-making skills.
• Ability to work with people at all levels.
• Conflict resolution and technical writing skills.
• Root cause analysis and problem solving.
• Influencing and negotiation skills.
• Communication skills in Spanish and English (technical), verbal and written.
• Ability to analyze complex problems in technical systems to gather conclusions of its functionality.

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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.