Specialist/ Principle/ Sr. Principle Specialist, Manufacturing Compliance

Location
Fremont, California
Salary
DOE
Posted
Feb 27, 2018
Ref
Job Number 180571
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Specialist / Principal Specialist / Sr. Principal Specialist, Manufacturing Compliance

 

Description:


Under minimal supervision, this position is responsible to manage projects, lead teams to investigate thorough investigations, and facilitate effective meetings.  This role is responsible to lead the following aspects within Manufacturing:

  • Deviation investigation and/Corrective and Preventative Actions (CAPA) completion,
  • Change control ownership
  • Project management
  • Trend key performance metrics
  • Participate in audits/inspection

This position is also responsible to complete specific projects and activities to keep Manufacturing prepared for audits and inspections. 

 

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:

  • New Product Introduction:
  • Supports the introduction of new product introduction activities and ensures procedural requirements are met.
  • Leads team to complete assessments on time, determine deliverables prior to introduction, and own the over-arching change control. Ensures deliverables meet procedural requirements.
  • Investigations and corrective actions:
  • Thoroughly investigates deviation events utilizing root cause analysis techniques.  Utilizes technical writing strategies to ensure content is clear, concise, and complete.  Leads team to evaluate pertinent aspects involved in determining deviation scope, impact, and to perform necessary evaluations to support conclusions.  Ensures corrections are initiated to address root cause and contributing causes discovered during investigation.
  • Inspection Preparation and Readiness
  • Responsible for maintaining inspection readiness within Manufacturing in the following ways: 
    • Generates play books for complex deviations, CAPA, and change controls.
    • Identify, propose, and executes compliance process and procedural changes to reduce deviations.
    • Implements corrective actions.
    • Provides hands-on training / guidance on MFG compliance, and reinforces cGMPs to increase quality and compliance knowledge throughout MFG organization.
    • Leads area walk throughs for housekeeping
  • Key Performance Indicators
  • Independently analyze data relative to defined KPI.  Make recommendations for improvement based upon the data gathered.

Requirements (Specialist Manufacturing Compliance):

  • Bachelors’ Degree with > 2 years of related professional experience
  • Experience leading projects is required
  • Broad technical knowledge of cGMP systems and experience with leading investigations, writing  deviation reports, owning change controls, and corrective actions
  • Understands manufacturing processes
  • Runs effective meetings
  • Skilled at creating and delivering presentations
  • Technical writing
  • Provides training and guidance to others

Desired Experience, Skills and Abilities:

  • Experience leading cross functional teams

Requirements (Principal Specialist Manufacturing Compliance):

  • Bachelors’ Degree with 4 - 6 years of related professional experience
  • Experience leading projects is required
  • Broad technical knowledge of cGMP systems and experience with leading investigations, writing  deviation reports, owning change controls, and corrective actions
  • Understands manufacturing processes
  • Runs effective meetings
  • Skilled at creating and delivering presentations
  • Technical writing
  • Provides training and guidance to others

Desired Experience, Skills and Abilities:

  • Experience leading cross functional teams

Requirements (Sr. Principal Specialist Manufacturing Compliance):

  • Bachelors’ Degree with 6 - 8 years of related professional experience or more
  • Experience leading projects is required
  • Broad technical knowledge of cGMP systems and experience with leading investigations, writing  deviation reports, owning change controls, and corrective actions
  • Understands manufacturing processes
  • Runs effective meetings
  • Skilled at creating and delivering presentations
  • Technical writing
  • Provides training and guidance to others

Desired Experience, Skills and Abilities:

  • Experience leading cross functional teams

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

Our Culture:

Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees.  Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.  Since we are privately held, we have the ability to take an innovative, long-term view.   Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families.  Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work.  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.

 

Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.