Boehringer Ingelheim Senior Manager, Validation Projects in FREMONT, California

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:

Responsible for leading a team that performs validation projects that support multi-product commercial manufacturing operations associated with bulk and drug product processes. Responsible for implementing mixing validation and transport validation among other critical quality validation topics. The senior manager is responsible for establishing validation best practices, and maintenance and management of validation processes at BI Fremont to achieve company goals and department objectives.

As a key member of Quality Validation department this role supports change controls, deviations and CAPAs relevant to validation topics, and takes part in Inspection Readiness Core Team. Participates in audit and inspection preparation and response activities. Assists or interacts with regulatory agencies. The senior manager shall be prepared to present and/or defend GMP documentation associated with quality validation practices. Works with functional areas to provide audit responses and ensure observations and resulting CAPA's, if any, are adequately addressed.

Participates in cross-functional meetings representing Quality Validation. Works with colleagues at other BI sites and external contractors to advance projects and to meet department goals. Able to lead validation risk assessments, conducts validation workshops, and provides site wide validation training as necessary. Coordinates with global teams to apply network policies, develop site-specific validation procedures and shared practices as applicable.

Accountable for staff effectiveness making sure validation projects are completed on time or as agreed with internal customers. Provide guidance to staff in preparing protocols, executing validation projects, developing approaches and strategies, alignment with BI procedures and industry best practices.

Ensures programs and processes are aligned with Corporate/Global BioPharma and maintained in accordance with cGMP/Quality/Compliance regulations. Fosters quality collaboration among the site and staff. Implements continuous improvement efforts as it relates to Validation activities.

Responsible for developing, reviewing and approval of validation plans, protocols, and reports. Reviews and interprets data for accuracy and responsible for approval of final report packages.

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:

  • Accountable for validation of mixing and transportation. Responsible for coordinating with cross-functional departments for planning, preparation, and execution of validation/re-validation projects. Manage resources, ensure timely completion of validation projects. Responsible for maintaining

  • the validation program in an audit ready state.

  • May act as a Local MSO for specific validation programs. As local MSO maintain the program in accordance to current regulations and in alignment with BI Corporate and Global BioPharma standards. Coordinate with other BioBU sites for investigations, and implementation activities to drive continuous improvement of processes. Participate actively as a core team member for revision/improvement efforts associated with global procedures.

  • Reviews and approves validation plans, protocols, and reports. Manage troubleshooting efforts for protocol discrepancies. Investigates deviations associated with failures in relevant validation projects. Applies theory, technical principles, and judgment to address a broad range of difficult projects/problems.

  • Reviews and interprets data for accuracy and responsible for approval of final report packages.

  • Reviews batch records/procedures to ensure that the process is within validated state. Performs validation impact assessments when changes are proposed.

  • Provides technical input to validation deviations; provides assessments for change requests; and identifies requirements to ensure the validated state is maintained.

  • Acts as an individual contributor as necessary developing validation protocols, executing and summarizing the results in a validation report.

  • Plans, schedules, directs, evaluates, and manages the work assignments to meet the department goals in terms of quality, productivity and efficiency. Also develops, implements and maintains resource planning tools in order to project staffing needs and manage cost.

  • Determine goals for the team based on department and organization goals. Determine individual goals for employee and monitor at regular intervals. Drives employee 1:1 discussions to provide feedback, performance review, strengthen focused areas, motivate, mentor, and support.

  • Serves as Subject Matter Expert for internal or external customers. Participates in inspection readiness activities and is significantly involved in inspections by regulatory agencies. Mentor and support staff by providing guidance in decision making, determining validation strategy, authoring complex documents and executions. Provides technical support and guidance to other project team members in protocol preparation, execution and data interpretation.

  • Provides guidance to junior team members on proper documentation and guidance interpretation.

  • Coach and train staff on validation. Responsible for mentoring and coaching Staff. Provides effective leadership according to AAI and leadership principles. Motivates, retains and develops key employees. Develops employees and ensure adequate skill sets in accordance with Talent Management based on performance dialogue, performance evaluation and individual career development plans (including training plans)

  • Ensures that the right skills and capabilities of people in the Validation function are developed to enable the organization to be flexible/adapt to the dynamic business conditions

Requirements:

  • Bachelor's degree from an accredited institution with a minimum of nine (9) years in the pharmaceutical industry with direct experience in cGMP environment, quality experience, knowledge of Validation Lifecycle Approach preferably in biopharmaceuticals, including four (4) years of experience managing/directing people or projects required; Masters Degree from an accredited institution with six (6) years in the pharmaceutical industry with direct experience in cGMP environment, quality experience, knowledge of Validation Lifecycle Approach preferably in biopharmaceuticals, including four (4) years of experience managing/directing people or projects preferred

  • Possesses excellent verbal and written communication skills; good interpersonal skills.

  • Thorough knowledge of GMP Pharmaceutial manufacturing.

  • Advanced knowledge of relevant regulations and guidances required in order to act as a resource for colleagues.

  • Independent decision making capability and ability to think conceptually and understand impact of decisions critical to product quality.

  • Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.

  • Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.

  • Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.

  • Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making.

  • Technical:

  • Expert in lead risk assessments, execute critical decision making, champions problem resolution, and provides compliant and smart solutions for complex validation issues. Expert understanding of validation principles in pharamceutical / biopharmceutical / medical device industries.

  • SME for validation topics in alignment with regulatory authority expectations. Demonstrates expert understanding of validation strategy, and validation impact assessments. Presents validation sampling plan commensurate with process requirements.

  • Leadership:

  • Requires excellent interpersonal, investigative and implementation skills. Demonstrated influencing, relationship building, and effective facilitation and change management skills.

  • Excellent communication skills with the ability to build rapport with management and employees and contribute to all aspects of an organization.

  • Strong leadership skills with proven ability to lead, engage, motivate, and develop the workforce.

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

Who We Are:

At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com at http://www.boehringer-ingelheim.com/ and join us in our effort to make more health.

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.

Organization: US-BI Fremont

Title: Senior Manager, Validation Projects

Location: Americas-US-CA-Fremont

Requisition ID: 190406