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QA Validation Manager - Hopewell, United States - BeiGene
Description
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description
Responsible for providing quality oversight for the qualification and validation activities for equipment, utilities, and facilities supporting large molecule clinical and commercial manufacturing (DS and DP), QC, and warehouse operations.
This role will be responsible for reviewing and approving qualification protocols/reports and any associated documentation in support of CQV activities for a new facility.
Works to support QA Key Performance Indicators (KPIs) such as SOP mandated cycle times, on time closure dates, and QA objectives, whilst adhering to regulatory compliance and achieving business success.
Essential Functions Of The Job
Assist in development, review, and approval of cGMP documents including, but not limited to: Master Validation Plans, FAT/SAT documents, Turnover Packages, SOP's, specifications, traceability matrices, thermal mapping documents, and design documentation.
Support validation activities for project activities including review of validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ) and attendance at validation activities.
Ensuring that the Quality department meets or improves key performance indicators (KPIs). Works to ensure assigned projects are on time, on budget, and have the required QA support.Provide QA support to enforce CQV guidelines, policies and procedures for equipment, analytical equipment, utilities, and facilities (Examples: Chromatography Systems, harvest hold tank, Lyophilizers, washers, autoclaves, gas distribution system, HVAC, etc.
Employee will be required to work closely with Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.
Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.
Ensuring the business stays current on new technology, validation techniques, and risk-based approaches.Undertaking any other duties for any department within the business, which may be requested by the QA Manager, for which training and/or an explanation has been provided and understood.
Core Competencies, Knowledge, and Skill RequirementsBachelor's degree in Science (ideally:
pharmaceutical sciences, engineering, chemistry, or related discipline).
Minimum of 5 years' experience in validation, biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.
1-3 years in a quality assurance or quality control role in an FDA-regulated companyStrong knowledge of cGMP's 21CFR parts 2010 & 211, knowledge of 21CFR600 – Biologics desirable.
Demonstrated knowledge of ISPE Baseline Guide 5, ASTM E-2500, EU regulatory requirements, and GAMP 5 Validation Lifecycle.
Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches.
Demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
Good collaboration and good project management skills.
Credible and confident communicator (written and verbal) at all levels.
Customer focused, Strong analytical and problem-solving ability.
Hands-on approach, with a 'can do' attitude. Able to work under minimal supervisor.
Ability to prioritize, demonstrating good time management skills.
Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
Self-motivated, with the ability to work proactively using own initiative.
Committed to learning and development.
Highly Desirable:
Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook).
Significant Contacts
Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.
Supervisory Responsibilities
Individual Contributor, no direct reports that works as part of the QA Validation team - may manage contractors as assigned.
Computer Skills
Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint); knowledge of SAP QM module
Ability to work on a computer for extended periods of time
Travel
Must be willing to travel approximately 5-10%; requires a valid passport.
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity
Salary Range:
$104, $144,400.00 annually
BeiGene is committed to fair and equitable compensation practices.
Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location.
Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only.Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan.
All Company employees have the opportunity to own shares of BeiGene Ltd.stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.
The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer and we value diversity.BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.
All employment is decided on the basis of qualifications, merit, and business need.#J-18808-Ljbffr
