Senior Specialist, Quality Assurance
Company: Boehringer Ingelheim
Posted on: April 10, 2021
Boehringer Ingelheim Fremont is the rapidly growing US arm of
Boehringer Ingelheim's Biologics Business Unit. We are a fully
integrated biologics operation with over 500 scientist and
specialists, covering cutting edge early- to late stage CMC
development, clinical and commercial drug substance and drug
product manufacturing, medical device assembly for combination
products and packaging operations.
We are continuing our rapid growth, investing over $200m into the
expansion of our capacity and capabilities, and creating
approximately 200 new jobs.
Driving this growth is an exciting pipeline of multiple Boehringer
Ingelheim novel biologic entities (NBEs) and biosimilars, as well
as, a growing diverse portfolio of therapeutics we develop and
manufacture for other leading pharma and biotech companies. This
includes multiple commercial product launches planned over the next
couple of years, for which we can tap into Boehringer Ingelheim's
unique experience of having brought 30+ biologics to market
Leveraging our diverse talent pool, we are also driving technology
and innovation globally, through major investment and
collaborations into next generation manufacturing platforms and
technologies, which may change how biologics will be made in the
Whether we work on our own products, help partners to bring their
products to market or innovate new technologies and approaches -
Everything we do, we do to help patients! #LI-MS1 *I-SF1 PDN1
Works independently to provide leadership and oversight to junior
QA team members as they provide QA oversight of any area of the
business responsible for adhering to current Good Manufacturing
Practices (cGMPs) including critical utilities, (e.g. WFI, Steam,
Automation, equipment, HVAC, etc.), warehouse, manufacturing
processes, inspection, labeling and packaging, batch record review,
batch disposition, new product introduction/product transfer,
external quality and laboratories. Utilizing a wealth of previous
experience, provides a high level of independent judgment and
discretion in the timely identification, investigation and
resolution of events impacting the Quality of products and
processes. Quality oversight responsibilities include ensuring
adherence to SOPs and requirements, proper change control,
corrective action and preventive action plans (CAPA)/Deviation
management, impact assessments for changes to equipment and
processes, risk management, and to ensure documentation and
investigations meet BIFI and regulatory standards. With autonomy
and authority, makes difficult decisions with little time for
deliberation which may have a direct impact on active manufacturing
operations, the release of equipment, systems, or areas.
Responsible for mentoring, coaching, may act as a delegate to sign
official documentation in the place of management, and makes
difficult decisions with little time for deliberation that can have
a direct impact on active manufacturing operations, the release of
equipment or area, or product release. Implements continuous
improvement efforts as it relates to QA activities. Indirectly
leads others within the QA Team under the leadership of the area
head. Fosters quality collaboration among the site and QA
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
Duties & Responsibilities\:
- Responsible for both executing the tactical operations and
overseeing junior team members as they assess, evaluate, and review
operations on the floor (as defined above) against cGMPs to assure
real-time observation of activities, issue identification/
resolution including proper and timely documentation. Provides
guidance to all GMP areas (i.e. MFG, E&T, QC, etc.) to ensure
compliance with all applicable regulations and assists in
resolution of issues identified. Information must be pro-actively
shared across QA and the business including the on-going training
of junior team members.
- Independently serves as QA representative in decision making
and conflict resolution with junior team members as needed in the
absence of the department head.
- Identifies, classifies and reports deviations, as appropriate
and typically works on complex Major deviations and/or complaints.
Oversees execution of remediation/CAPA activities required to
continue production or move a process to the next milestone. Works
closely with others to determine root cause and potential
preventative/corrective actions. Ensures support for the timely
closure of investigations.
- Authorized to suspend any operation when the situation
warrants. Provides guidance and control directives regarding
remediation activities required to continue production. Is required
to resolve critical issues utilizing independent judgement and
decision making as a senior level of the department. May serve as
the final decision-maker in situations requiring the Sr. QA
Specialist to utilize the input of others to make a final
compliance determination. .
- May also be required to communicate with clients, external
vendors, external services to resolve investigations as warranted
to ensure compliance to regulations and local procedures.
- Responsible for providing quality oversight to the change
management system for complex Minor and/or Major classified Change
Controls. This includes providing plan creation oversight,
verifying that changes adhere to local SOPs and regulatory
compliance and ensuring communication/escalation of potential
issues of broader impact to the business. Sought after by junior
team members for guidance in the quality oversight of changes
within the Quality Management System including approriate
stakeholders reviews are completed such as Regulatory, Client, Area
- Performs independent technical review of documentation during
and post-execution of cGMP activities. Has authority to sign
off/qualify/train junior staff on QA Operation responsibilities.
Ensures all specifications are met and that applicable requirements
are completed and acceptable. Ensures all issues/documentation
associated with each process in assigned area have been resolved
and Approved prior to release to the next step and are compliant
with cGMPs and SOPs and current manufacturing regulations and site
procedures. Analyzes and reports findings to appropriate
- Works closely with others in the assigned area to recognize
opportunities for improvement and drive change through the use of
BIFI's Quality Systems. May be a certified Green-Belt and assigned
to lead process improvement initiatives via the BPE program. May
also attend, as a QA project team member to provide QA guidance and
oversight to such improvements.
- Will serve as Subject Matter Expert for internal or external
matters. Participates in inspection readiness activities and is
significantly involved in inspections by regulatory agencies.
- Models effective and constructive communication behaviors and
interactions with technical departments, junior team members and
senior business leaders, both orally and in writing; maintain
acceptable proficiency in technical and non-technical (e.g.
- Is proficient in technical and non-technical (e.g.
interpersonal) skills to ensure the continued success of the
department and quality of oversight provided to the business.
- Creates and establishes processes and procedures to ensure
compliance and adherence to regulated QA activities for cGMP
- Mentors, trains and coaches new personnel as required and
supports the development and implementation of training programs.
Available to act as a resource for colleagues with less experience
regardless of level. Will provide input on the performance of
junior team members to the department head as part of the
performance management process.
- Requires a Bachelor's or higher degree from an accredited
institution preferably in sciences.
- Requires a minimum of five (5) years of experience working in
the Quality aspects of a life sciences or closely related
- Requires a minimum of one (1) year of experience managing
projects and priorities within complex matrix organizations.
- Must have demonstrated ability to execute against the strategic
and tactical objectives provided by senior leaders both within
Quality and outside of the function.
- Strong independent judgment and decision making abilities
- Experience leading people and/or 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.
- 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..... click
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Keywords: Boehringer Ingelheim, Fremont , Senior Specialist, Quality Assurance, Other , Fremont, California
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