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.
Sr. Specialist - Quality Systems-1811967
This position is responsible for implementing, maintaining, and monitoring Quality System processes. This includes leading skilled people, and identifying and implementing business process improvements that will drive Fremont’s business performance and Quality innovation.
Incumbent provides technical expertise on Quality Systems standards and processes to team members.
Ensures programs and processes are aligned with Corporate/Global BioPharma and maintained in accordance with cGMP/Quality/Compliance regulations.
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
- Implements and maintains BI Fremont Quality Systems. Engages Network to ensure alignment with Corporate/Global BioPharma sites and operating units. Represents process during internal/corporate client audits and health authority inspections.
- Key User/Point of Contact for Quality Systems. Provides process and system training for site staff involved with the Quality System process.
- Leads or is involved in BPE/BIOS projects.
- Supports Deviation/CAPA/Investigations Process Owner
- Site SME and Support role for Quality System related activities.
- Supports inspection readiness activities and fills inspection execution roles.
- Supports Quality Risk Management Process Owner by facilitating risk assessments and incorporating Risk Management principles into Quality Systems, as needed.
- Leads/Participates in cross-functional investigations or assessments in support of investigations, change controls, or other compliance activities.
- Requires a Bachelor's degree, from an accredited institution, in Microbiology, Biology, Chemistry (Or closely related degree with these core courses as the foundation)
- Requires eight (8) years of quality pharmaceutical experience with oversight provided to Manufacturing Operations, QC, and other cGMP areas.
- Strong independent judgment and decision making abilities required.
- Experience leading projects with history of achieving results and outstanding outcomes.
- Advanced knowledge of relevant regulations and guidances required in order to act as a resource for colleagues.
- One (1) to three (3) years proven project-management skills required. Must be able to manage multiple projects against given time-lines.
- Demonstrated hard-working and productive work ethic in an ambiguous environment strongly preferred.
- Independent decision making capability and ability to think conceptually and understand impact of decisions critical
- Possesses strong conflict resolution and negotiation skills
- Must be able to independently represent the department in a wide-assortment of situations
- Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
- Must possess excellent verbal and written communication skills; good interpersonal skills.
- Must have experience ensuring respectful interactions with individuals with diverse views or backgrounds.
- Ability to work independently.
- Familiarity with Quality Management Systems and related regulatory guidelines
- Knowledge of where to go within the organization for needed information and ability to judge what information should be passed on to different levels of management or organizational units.
- Demonstrated analytical skills and a system approach to problem solving with an emphasis on process development and optimization, not just system maintenance.
- Demonstrated ability to deliver solutions in a timely fashion under rapidly changing conditions.
- Highly regulated (FDA, DEA, EMEA, and EPA). Significant technical/operational risk due to increasing legal and regulatory complexity.
- May 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
- The combination of intense regulation (i.e. pharmaceutical production, controlled substances, environmental and safety, etc.), overall risk of operations in a complex business/operational model with multiple competing factors needing to be balanced.
- Coordination and communication between multiple departments, including Manufacturing, Process Science, Quality and other functional areas.
- Work is primarily directed at the site; however, may interact with colleagues at other USA and worldwide sites.
- May be required to travel nationally.
- To be qualified for this position must meet the following:
- Physical Demands / Surroundings-Requires physical activity such as almost constant standing, walking, eyestrain, etc. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.
- Visual Demands - Eyestrain associated with the use of computer terminals and routine / repetitive work.
- Temperaments/Mental Requirements - The position requires concentration as errors might cause moderate to serious delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
- Level of Proficiency - Experienced level subject matter proficiency required with technical expertise such that corrective actions resulting from procedural deviations are effective in a timely manner and that any changes to processes and procedures follow relevant change control procedures.
- Attendance / Schedule- The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies.
- To remain in this position, employees:
- Must obtain & maintain qualifications, as required, to perform the assigned work.
- Must understand, will be held accountable for and must adhere to all SOPs, company Policies and Procedures
- Must adhere to proper technique, proper documentation practices, and all other aspects of the cGMP’s
- Must maintain all training requirements and regularly checks the LOS training system in order to complete all required training on time.
- 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.
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.