Boehringer Ingelheim Manager, CMO Quality Assurance (St. Joseph, Athens, or Duluth) in SAINT JOSEPH, Missouri
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.
Responsible for ensuring quality and compliance of products contract manufactured and tested on behalf of BI as well as respective suppliers and service providers (APIs, ingredients, contract laboratories, etc.) by:
Ensuring processes related to external manufacture and internal processes are in compliance with applicable cGMP requirements (Federal, State, Local and international regulations, including compliance to all company procedures and policies) including CMO Quality Systems related activities such as product documentation review, change control, complaint management, deviations, laboratory investigations, PQRs and stability studies.
Assisting with regulatory inspections of CMO operations and supporting regulatory inspections at CMO's/suppliers/service providers, as it pertains to BI products manufactured or tested there.
Preparing and maintaining comprehensive quality agreements with all contract manufacturers, suppliers, service providers (where required) and internal partners.
Managing quality related tasks during analytical and product transfers.
Position assists with setting QA standards for work, processes and behaviors to control and mitigate risk associated with the regulatory requirements and product quality.
In addition, this position assists with development of strategic objectives for the CMO quality operations and supports Regulatory Affairs in answering inquiries from regulatory bodies regarding the CMC section of the dossier.
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:
Maintains compliance to procedures and processes to ensure all batches are manufactured in compliance with cGMP (FDA, EU and other Federal, State, Local and international regulatory bodies), BI quality manual requirements and registered dossiers.
Creates procedures in alignment with the Head of Quality Systems according to regulatory guidance (FDA, EU, etc.), revises and updates procedures to ensure compliance to evolving regulations, and assists with the development of systems to maintain product quality and compliance for products manufactured on behalf of BI.
Creates and approves quality agreements with CMOs, suppliers and service providers (where required).
Ensures product documentation review, complaint management, laboratory investigations, APRs/PQRs, stability studies, quality agreements and manufacturing documentation comply with applicable regulations and company procedures and policies.
Create and follow-up defined measures from APR/PQR review.
Create documents that answer inquiries from authorities regarding CMC in coordination with Regulatory Affairs.
Create “expert statements,” which does not include the creation of detailed and critical summaries.
CMO Management accountabilities also include:
Answering regulatory authority requests during inspections related to e.g. CMO quality oversight topics.
Answering Divisional and Corporate Quality inquiries
Answering requests from domestic and international business partners (Supply Chain, Operations, Quality, Third Party Manufacturing etc.)
Executing continuous improvement and CAPA processes at the CMOs through quality oversight, quality expert and annual business review meetings.
Identifying risks at contract manufacturers and drives risk reduction measures to ensure contractors operate in a state of compliance.
Executes both long and short term regional, divisional and Corporate Quality strategic direction for the following :
Quality Operations activities including e.g. complaints, deviations and laboratory investigations
Oversight of suppliers and contract laboratories ("contractors") quality and CMO activities
Ensures associated contractor sites and CMOs apply quality systems in compliance with external and internal regulatory quality guidelines and cGMP standards as well as 3PQM specific quality procedures.
Participates in Third Party Quality Management Review Process and supports monitoring of metrics and performance reporting according to local procedures.
Performs all company business in accordance with all regulation (e.g. Equal employment opportunity, FDA, EU, etc.) and company policy and procedures. When violations are noted/observed they are to be immediately reported to management.
Demonstrates high ethical and professional standards with all business contacts in order to maintain BIs excellent reputation in the community.
Acts as Regional MSO for certain assigned functions in close alignment with Head of Quality Systems.
Product design review (PDR analysis)
Creates and conducts phases I-III in line with PDR concept
Creates, harmonizes, and coordinates remediation plans (phase IV)
Follows up implementation of activities in line with defined remediation plan
Participates in “phase out” activities (discontinuation)
Supervise pharmacy interns as part of their training in accordance with Section 4 of the German Approbation Regulation for Pharmacists.
Bachelors or Master’s degree (e.g. MBA or MSc) in chemistry, biology, life sciences or pharmaceuticals from an accredited institution required
The incumbent must be able to work through the CMO to achieve desired results. This requires establishing a collaborative, open, transparent and supportive relationship with the CMO ensuring the responsibilities and accountabilities described herein can be met.
Five (5) years’ experience in Pharmaceutical Quality cGMP environment required. Ability to lead, motivate, influence and coach others. Ability to exercise independent judgment. Ability to design strategies to ensure success of product documentation review, quality processes, SOPs, and investigations.
Knowledge of global quality requirements (FDA and EMA regulations) and their effect on manufacturing and testing of pharmaceutical products. Possess thorough working knowledge of current Good Manufacturing Practices and Good Laboratory Practices as they pertain to Quality Operations required.
Possess excellent communication skills (verbal and written including technical report writing and oral presentations) and demonstrated ability to influence/persuade individuals to gain acceptance of an idea or implement process improvements. Ability to shift thought processes quickly and accurately from one project to another. Ability to effectively present technical information and to respond to inquiries or complaints from employees, managers, vendors, or regulatory agencies. Ability to establish and maintain effective working relationships with colleagues, and management and all levels within the Corporation.
Must possess strong analytical thinking skills. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to define problems, collect data, establish facts and draw valid conclusions to make informed decisions and recommendations.
Possess strong computer skills required in MS Office Suite and GoTrack.
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
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 neighbourhoods 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.
Title: Manager, CMO Quality Assurance (St. Joseph, Athens, or Duluth)
Location: Americas-United States-MO-Saint Joseph
Other Locations: Americas-United States-GA-Athens, Americas-United States-GA-Duluth
Requisition ID: 189523