Operations/quality manager job description

Oxford Biomedica Solutions, LLC, the joint venture of Oxford Biomedica plc and Homology Medicines, Inc., is seeking a Manager, Quality Assurance Operations to be responsible for QA oversight of Quality Control and supporting activities. This key team member will partner with QC staff to play a vital role in establishing a right-the-first time quality culture, enabling efficient issue resolution, and driving efficient processes and continuous improvement. This Quality Assurance Operations Manager is responsible for: analytical method transfer and qualification, stability program oversight, EM/Utility Program, compliance, and CoA approvals to support product disposition. Additionally, this team member will work cross-functionally to support quality assurance activities including batch/solution record review, manufacturing deviations, change controls, and QC analytical instrument qualifications. Bring your innovative mindset to help us build a transformative quality department and support the growth of the organization as we work to produce gene therapy AAV therapeutics to improve patients' lives.
Responsibilities
• Quality lead for analytical method transfers and qualifications related to new product introductions and method improvements.
• Review and approve QC related SOPs and analytical methods and associated executed data.
• Oversight of stability programs including review and approval of protocols, data/results, reports.
• QA contact for QC related deviations, lab investigations, and Out of Specification results.
• Review and approve EM/Utility excursions and reports associated with EM program.
• Primary contact for release of raw materials to support GMP activities.
• Support manufacturing operations activities as needed including batch record review, quality system record ownership and approval, and facilities documentation approval.
• Participate and support lot disposition activities.
• Contribute to the development of metrics and KPIs.
• Drive continuous improvement initiatives.
• Champion a Culture of Quality and ensure a safe working environment.
Qualifications
• Bachelor's degree in chemistry, biology, microbiology, or equivalent, with a minimum of 8 years of experience in the pharmaceutical/biotech industry.
• Comprehensive knowledge of quality principles and FDA/EU GMP regulations.
• Effective decision maker that has demonstrated ability to assess, manage and navigate quality and compliance risks.
• Exceptional technical writing and interpersonal skills; proven ability to interact effectively with all levels within the organization, external third parties, and with regulatory authorities.
• Able to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
• Self-driven, independently motivated, detail-oriented, and organized, with excellent problem-solving skills.
• Brings an innovative mindset to the application of quality principles; able to lead, problem solve, and work autonomously, with flexibility to accommodate to rapidly changing priorities and deadlines.

Your Career Begins at Timken
If you're ready for a challenging career that provides you with the ability to advance personally and professionally, look to Timken. Our associates make the world more productive by improving the efficiency and reliability of the machinery that keeps industry in motion. Purpose & ScopeThis position exists to ensure that all products assembled and shipped from the New Philadelphia Bearing Plant meet customer expectations for quality specifications, including documentation and certification. Essential Responsibilities

• Visually and dimensionally inspect product for conformance to specifications
• Set up and adjust gauges for checking product using masters and hand tools
• Verify machine set-ups per engineering specifications
• Ensure accuracy of product identification/marking
• Ensure accuracy of production transactions
• Conduct government audits, source inspections, as well as incoming and outgoing audits
• Ensure accuracy of all required documentation including Blue Books and all in-process documentation, as required by the Company, the customer and/or the United States Government
• Adhere to all safety standards Technical/Functional Skills Required:

• Strong reading, comprehension, and attention-to-detail skills
• Solid communication, teamwork, and organization skills
• Basic shop math skills
• Basic computer skills, including web page navigation Minimum Requirements:
  • High School Diploma or GED and 2 or more years of relevant experience (5 or more years preferred)
  • Grinding/machining education and/or 2 years of precision grinding/machining experience (highly preferred) All qualified applicants shall be treated equally according to their individual qualifications, abilities, experiences and other employment standards. There will be no discrimination due to gender or gender identity, race, religion, color, national origin, ancestry, age, disability, sexual orientation, veteran/military status or any other basis protected by applicable law.
    
    

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.
**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 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. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

**Boehringer Ingelheim** is currently seeking a talented and innovative Co-Op candidate to join our Quality Strategy department located at our Fremont facility. As an Co-Op, you will work under the guidance of the Quality Strategy Lead and learn about strategic operating planning process. This internship will give you the experience and opportunity to work cross functionally with various departments and to forecasting resource needs at a functional level. 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:**

• Gather and review information from key stakeholders

• Analyzing and Maintaining work package database

• Facilitate process improvement projects

• Support departmental Leadership Team initiatives Requirements: Must be an Undergraduate, Graduate, or Professional Student in good academic standing. Must have completed 12 credit hours within a related major and/or other related coursework. Overall, cumulative GPA (from last completed quarter) must be at least 3.000 (on 4.0 scale) or better (No rounding up). Major must be related to the field of internship.

Desired Experience, Skills and Abilities:

• Problem Solving skills

• Strong communication skills

• Knowledgeable with Microsoft Office Suite

• Business Analytics tools such as Power BI or Tableau

**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.

**Organization:** _US-BI Fremont_

**Title:** _Co-Op, Quality Strategy Department, Fremont CA_

**Location:** _Americas-US-CA-Fremont_