Associate Director, Manufacturing Compliance Details

Associate Director, Manufacturing Compliance

Boehringer Ingelheim - Fremont, CA

Employment Type : Full-Time

This position leads a team of highly skilled SMEs to manage key GMP functions in drug substance and drug product manufacturing operations including deviation management, change management, compliance management and the commercial trending. This role leads a team of highly skilled SMEs. This role is a key link between Quality and Manufacturing organizations to release product and manufacturing areas for production.
This role and his/her team owns complex cross functional improvement projects large in scope and complexity and ensures successful implementation of the area's continuous improvement initiatives. This includes development of a long-term strategic plan for continuous improvement in alignment with site goals.
This role and his/her team interfaces regularly with clients and customers communicating the results of comprehensive investigations and change management and justifying proposed corrective actions to prevent future deviation events.
Incumbent provides technical expertise on Quality Assurance and Compliance standards and processes to team members; and provides input on strategy to the Director Manufacturing Compliance, Manufacturing and Quality Compliance and Quality Assurance teams.
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:

  • Leads and manages the work of the Manufacturing Compliance group to meet quality, productivity and efficiency goals and to achieve operation and quality goals and objectives. Accountable for effectively leading, driving and managing change in Manufacturing Compliance in a rapidly growing, highly dynamic environment.
  • Leads group to thoroughly investigate major and complex minor manufacturing deviations. Collaborates cross-functionally to gain alignment on compliance and quality issues. Ensures that deviation investigation meet current quality standards and that risk based decisions are applied.
  • Leads group to develop and control changes in the manufacturing area. Ensure that changes are defined, thorough, and controlled to ensure that validated status and areas are maintained. Implements changes that improve flexibility and innovation in the Manufacturing area. Provide manufacturing solutions to complex issues.
  • Manages the Key Performance Indicator program for the Manufacturing organization. Compiles, organizes, and analyzes performance to continually seek improvement areas.
  • Analyzes the resource demands for manufacturing compliance organization and develops a skill profile for his/her organization.
  • Ensures that positions are filled accordingly and the team members are developed appropriately through performance and talent management, succession planning and coaching.
  • Further, the position will be responsible for identifying and mitigating gaps in staff training, and establishing a development strategy for all manufacturing staff to ensure that the talents of the staff members are developed and talents are retained for the site / BI.
  • The position ensures the right amount of cross-training to enable flexible allocation of resources.
  • Leads team to manage trending program for commercial products including but not limited to timely generation of statistical reports, trends, summary reports and expert analysis.
  • Interview, hire, train, supervise, coach, motivate, develop and discipline Staff. Responsible for creating department goals and ensuring teams are on track to meet those goals. Assigns goals to meet scheduling requirements. Sets performance objectives and development plans. Monitor progress. Develop and train Managers and supervisors for growth and advancement.
  • Leads team to prepare manufacturing for audits and regulatory inspections.

Leadership includes:

  • Developing team to defend all aspects of drug substance, drug product and packaging operations
  • Developing team to prepare Associate Directors, Sr. Managers, Supervisors for the audits and inspections including housekeeping walk throughs directly in advance of audits, role play, tour practice sessions, knowledge expectations and review.

  • Provides strategic consultation to prepare the head of upstream, downstream, filling and packaging Associate Directors to defend complex topics.
  • Ensures compliance of manufacturing processes and systems as well as department activities with national and international cGMP (e.g. FDA, EMA) and Company Policies, Procedures, Goals and Objectives. Follows all relevant department policies, procedures, SOP and other requirements and act at all times within the BI standards/ethics policies. Strong understanding and appreciation for regulatory requirements and compliance standards under which the Fremont site is operating.
  • Participate in BI interactions with various governmental agencies/regulators and external auditors
  • Strong understanding and appreciation for regulatory requirements and compliance standards under which the Fremont site is operating
  • Coordination and communication between multiple departments, including Process Science, Quality, Engineering and other functional areas.
  • Coach and mentor head of upstream, downstream, filling and finishing on regulatory topics and audit preparation approaches.
  • Work is primarily directed at the site; however, may interact with colleagues at other USA and worldwide sites.

Requirements:
  • Requires a Bachelors degree from an accredited institution, preferably in a science or engineering related field with eight (8) years of cGMP pharmaceutical manufacturing experience in positions of progressive responsibility; Plus a minimum of five (5) years’ experience managing/directing people in a GMP environment or clean room assembly environment.
  • In lieu of a Bachelor's degree, will consider an Associate's degree from an accredited institution, preferably in a science or engineering related field with a minimum of ten (10) years’ experience including minimum of five (5) years proven record of managing/directing people in a GMP environment or clean room assembly environment
  • In lieu of a Bachelor's or Associate's degree, will consider a High school diploma/GED with thirteen (13) years’ experience including minimum of five (5) years proven record of managing/directing people in a GMP environment or clean room assembly environment.
  • Requires four (4) years of Leadership experience in a cGMP pharmaceutical manufacturing environment leading teams in a cGMP pharmaceutical manufacturing environment or equivalent experience.
  • A Subject Matter Expert of biopharmaceutical operations with respect to resource planning, regulatory requirements and quality and industry expectations.
  • Requires prior demonstrated Leadership competencies and strong interpersonal skills.
  • Experience interviewing, hiring, training, supervising, coaching, motivating, developing and disciplining Staff.
  • Experience overseeing highly skilled SMEs to perform and coach staff to explain investigations to regulatory personnel.
  • Excellent oral communication skills
  • Must be able to motivate and mobilize staff
  • Must exercise rapid learning ability, attention to detail, excellent computer skills, team player, organized analytical thinker with a high level of energy and self-motivation.
  • Ability to read, develop, and understand procedures and other controlled documents
  • Must have excellent written and verbal communication skills.
  • Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the manufacturing.
  • Demonstrated proficiency in MS Office programs and associated computer programs.
  • Must be able to work in a team environment.

Leadership:

  • Requires interpersonal, investigative and implementation skills.
  • Ability to think strategically and has strong business judgment
  • Demonstrated influencing, relationship building, and effective facilitation.
  • Excellent communication skills with the ability to Influence Cross functionally.
  • Ability to handle multi tasks and provide the leadership and strategy to a team

Technical:

  • Expertise in deviation management, change management, compliance management and the commercial trending.
  • Experience leading teams of SMEs.
  • Experience in managing continuous improvement initiatives.
  • Some experience in strategic planning for continuous improvement
  • Technical expertise on Quality Assurance and Compliance standards including audit readiness and audit management.

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 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., Boehringer Ingelheim Animal Health Puerto Rico 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; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.

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Job - Manufacturing/Operations/ Production Primary Location - Americas-US-CA-Fremont Organization - US-BI Fremont Schedule - Full-time

Posted on : 3 years ago
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