Description

The Manager QA role leads and oversights the disposition of raw materials, packaging components, in-process materials, and finished products on a timely fashion to assure business continuity. Manages the QA Release Team according to company policies and corporate business plans. Assure that QA Release functions are in alignment with product supply plans and performed according to regulatory requirements based on products market authorizations. Collaborates with other functional areas to assure compliance with site and area KPI's. Provides technical competence in events assuring agile and compliant resolution. Supports Quality Systems as SME, regulatory inspection and corporate audits and serves as a backup to the SR AD Quality & Compliance in the event of absence. This position also handles emergency and critical tasks within the QA team.

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

Duties & Responsibilities

• Leads and oversight of the disposition of raw
  materials, packaging components, in-process
  materials, and finished products timely. Collaborate
  with other departments, such as Production, Planning,
  Warehouse to assure achieve product supply.
• Assures proper usage decisions for batch/lot release
  in SAP according to the Market Authorization of the
  products.
• Coordinate the timely issuance of Quality KPI's
  (ROT). Collaborate to assures proper implementation
  and interpretation of KPI's. Take agile actions if
  necessary to achieve the KPI's goals.
• Ensure that any site event or discrepancy is
  investigated accordingly. Coordinate and/or conduct
  the investigation. Initiates (as needed), assesses,
  reviews and approves deviations. Assign deviations to
  team members.
• Collaborate with site's areas to perform immediate
  impact assessment on deviations to determine whether
  a quarantine, a field alerts are warranted. Writes or
  participates in deviation investigations for
  determination of root cause and product impact.
  Assures proper CAPA's identification.
• Leads and collaborate with all site areas to assure
  timely completion of deviations and CAPA's, avoiding
  impact to the product release.
• Direct the resolution of major issues applying
  Quality Systems knowledge and cGMPs.
• Provides guidance to the site's area and technical
  teams in the use and interpretation of company
  policies, procedures, standards, guidelines. Reviews,
  revises and/or approve SOP's as needed.
• Assures that QA documentation/procedures are
  maintained in compliance with current regulatory
  expectations/registrations according to the products
  Market Authorizations.
• Collaborates with the Internal Audit Program
  assuring the participation of QA Auditors team in
  monthly area's walk troughs and internal audits.
• Provides guidance to the areas to maintain a good
  Inspection Readiness status identifying
  inefficiencies / problems, and solutions timely.
• Seeks opportunities for continuous improvement focus
  in activities to strengthen site compliance posture
  and simplify processes.
• Supports all activities required to assure
  compliance with cGMP's on new products introduction/
  site transfer assigning personnel and providing
  compliance posture.
• Manage requests for documentation associated to
  regulatory submissions and/or samples needed are
  provided timely.
• Coordinate the activities to provide audited and/or
  certified information on time for documents needed
  for regulatory filing.
• Supports regulatory and corporate audits as SME,
  escort or any other role as required. Coordinate
  team participation as needed assuring documentation
  completeness, review and availability.

Requirements

• Bachelor degree from an accredited institution in Sciences (Engineering, Biology, Chemistry, Pharmacy or scientific discipline like computer science).
• Minimum of seven (7) years of experience in a pharmaceutical, bio-pharmaceutical or medical devices cGMP environment.
• At least five (5) years of experience working in quality, compliance or related field.
• Minimum of three (3) years of supervisory experience.
• Broad experience in analytical procedures, instrumentations, manufacturing practices and procedures is highly preferred.
• Audit preparation for regulatory agency audits/inspections and participation through demonstration of job tasks during inspections may be required as needed.
• Strong understanding of cGMP's, FDA, EMEA, ICH regulations, MCA, and others.
• 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.
• Able to analyze complex problems in technical systems to gather conclusions of its functionality.

#LI-KD1

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

• Manages a comprehensive response to regulatory and
  internal cGMP's observations associate to area of
  expertise. Supports production and service areas in
  the evaluation of responses according to cGMP's and
  company policies.
• Drives the continuous improvement of processes,
  systems and culture in the organization. Model
  behaviors aligned with the site continuous
  improvement mindset, implement ideas, programs and change management initiatives that will have
  sustainable long-term benefits according to the
  organization strategic goals and objectives.
• Drive Environmental, Health and Safety (EHS)
  compliance in the organization. Actively engage and
  role model behaviors aligned with the site EHS
  philosophy and assure full on-time compliance with
  applicable EHS training programs and requirements.
• Empower, motivate and drive people development.
  Assure annual performance review activities be
  conducted on time. Promote and engage 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.
• Complies with all environmental guidelines,
  procedures, training, practices, permit conditions,
  and internal notification of any environmental
  events. Complies with regulatory training,
  procedures, policies and guidelines.
• Support preparation of department budget for Quality
  Assurance area. Monitors spending to stay within
  prescribed limits and proposes and develop new
  budget information. Identify and explore new ways
  for savings to improve spending.
• Other tasks or projects as assigned.