The Executive Director of Quality Assurance leads a team of managers, supervisors, technical and clerical support across a multi-layered organization who provide the quality oversight functions for a significant portion of Ben Venue’s quality unit. The organization oversees the Quality Assurance Audit Specialists, Quality Investigators, Documentation Management, Batch Release, Quality Data Management, Change Control, Deviation Management and Product Development Quality units. In addition, this individual is responsible for driving system improvements throughout the Annual Product Review, continuous process improvement, and quality data reviews.
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:
Manages the execution of multiple quality oversight components of the commercial aseptic filling operations including raw material and product release, batch record review, Quality oversight of GMP warehouse and engineering functions, use and integration of global quality processes in systems improvement.
Responsible for the product release function, ensuring the product has been made per approved procedures and meets quality testing specifications.
Responsible for tracking and reporting key Quality Metrics and the timely completion of monthly reports.
Responsible for overseeing the PPD Quality organization.
Responsible for out of specification (OOS) review in conjunction with the Analytical Laboratory Manager.
Responsible for the QA review of the Environmental Monitoring Program including monthly, quarterly and annual reports.
Provides guidance for BVL’s Contract Product Quality Support Program and act as liaison between BVL and clients on quality related issues.
Develop and implement new SOPs and/or Quality Programs as needed.
Provide support and advice concerning Batch dispositions, new systems for improving the quality of products, industry norms, regulatory updates, training programs.
Recommend handling of potentially non-conforming product; investigate and identify root causes of product failures and coordinate with other members of management to resolve the non-conformance.
Requires a Bachelor of Science degree in a scientific discipline closely related to pharmaceutical operations, Science or Pharmaceutics, and/or professional training
Excellent Communication skills (oral & written) in order to sell/convey expectations, goals and objectives across the department as well as the organization.
Technical & experiential background in aseptic manufacturing processes, principles of validations and cGMP principles.
Skilled at coaching & mentoring to develop the “next” company leaders.
Demonstrated strong leadership and decision making abilities along with skills in scheduling and planning.
Proficiency in the use of Microsoft Office and other computer software relevant to the position.
Minimum 5 years of leadership experience
Desired Experience, Skills and Abilities:
Minimum 8 years pharmaceutical industry experience in laboratory, regulatory support, quality assurance, validation or manufacturing activities.
Minimum of 5 years supervisory experience in microbiology, chemistry, laboratory, process validation, regulatory affairs, CMC writing or review, manufacturing quality assurance or documentation batch release.
Prior experience must include aseptic manufacturing and liquid visual inspection experience.
Must be legally authorized to work in the United States without restriction.
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. 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. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
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 background investigations and drug screenings.
Ben Venue Labs
As the US headquarters of German drug maker Boehringer Ingelheim, Boehringer Ingelheim Corporation oversees about half a dozen stateside...