Address
Form of workWho we are
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
The Senior Manager Quality Assurance manages the QA Team responsible for quality oversight of analytical Quality Control. This oversight encompasses: release and stability testing of Raw Materials, Cell Banks, Bulk Drug Substance, and Drug Product. The incumbent must apply sound scientific principles to meet quality and business goals and possess the acuity and authority to serve as the delegate for the Head of GMP Quality Assurance.
How you'll spend your day
Serve as delegate/secondary to the Head of GMP Quality Assurance during high level project planning meetings and serve as the Quality Assurance Authority for the following:
Critical Quality Attributes (CQAs) include "physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality". The CQA committee will participate in the identification and risk assessment of quality attributes, taking into account the target product profile, molecular design, process understanding, risk management and control strategies for the CMC biologics portfolio products at three stages from pre-clinical development to license application. The CQA committee is a cross-functional team with stakeholders from various groups within CMC.
Responsible for critically evaluating and endorsing the proposals for new and when applicable, revised product Specifications as presented by the Analytical Development group and providing recommendations and/or endorsement of the decisions requested.
A group with members from Analytical Development, Process Development, Drug Product Development and Operations, Quality Control, Material Sciences, Quality Assurance, and Manufacturing (Planning and Operations) who is consulted on any specification initiations, changes, or retirements to ensure appropriate testing of controlled materials.
Additional Responsibilities, as needed / Preferred Experience
Your experience and qualifications
Enjoy a more rewarding choice
We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance.
Reports To
Amy Fluck
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva's Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
This position is not eligible for sponsorship. To be considered for this opportunity, you must apply on our career page.
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
The Senior Manager Quality Assurance manages the QA Team responsible for quality oversight of analytical Quality Control. This oversight encompasses: release and stability testing of Raw Materials, Cell Banks, Bulk Drug Substance, and Drug Product. The incumbent must apply sound scientific principles to meet quality and business goals and possess the acuity and authority to serve as the delegate for the Head of GMP Quality Assurance.
How you'll spend your day
Serve as delegate/secondary to the Head of GMP Quality Assurance during high level project planning meetings and serve as the Quality Assurance Authority for the following:
- Critical Quality Attribute Committee:
Critical Quality Attributes (CQAs) include "physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality". The CQA committee will participate in the identification and risk assessment of quality attributes, taking into account the target product profile, molecular design, process understanding, risk management and control strategies for the CMC biologics portfolio products at three stages from pre-clinical development to license application. The CQA committee is a cross-functional team with stakeholders from various groups within CMC.
- Product Specification Oversight Committee:
Responsible for critically evaluating and endorsing the proposals for new and when applicable, revised product Specifications as presented by the Analytical Development group and providing recommendations and/or endorsement of the decisions requested.
- Raw Material Specification Oversight Committee:
A group with members from Analytical Development, Process Development, Drug Product Development and Operations, Quality Control, Material Sciences, Quality Assurance, and Manufacturing (Planning and Operations) who is consulted on any specification initiations, changes, or retirements to ensure appropriate testing of controlled materials.
- Stability Review Committee: the responsibilities of this Committee include
- Review and endorse stability study designs and batch selection
- Review stability trend evaluation findings
- Review and endorse stability shelf-life assignments
- Review and endorse product temperature excursion matrices
- Decision-making Authority (go/no go) for Quality Control GMP activities including:
- Quality evaluation of Product Stability Program
- Quality evaluation and approval of Product Specification creation/revision
- Raw Material Specification creation/revision
- Analytical QC Release Data of Product and Raw Materials
- Pre/Post Approvals - Analytical Development Method Qualification
- Pre/Post Approvals - Analytical QC Method Validation
- Direct management of a team of Quality Assurance Analysts
- Ensure activities are performed/completed using current Good Manufacturing Practices.
- Review of analytical testing data for accuracy/completeness/cGMP documentation.
- Serve as a subject area Quality Assurance SME, representing QA on multi-functional teams in support of assignments and investigations.
- Provide feed-back/communication of any issues.
- Review and approve analytical method validation protocols, method transfer protocols, stability protocols, and technical reports.
- Review and approve SOPs, work instructions, and controlled forms.
- Utilize Quality Metrics Systems to review and approve change controls, deviations, laboratory investigations, CAPAs and CAPA Effectiveness checks.
Additional Responsibilities, as needed / Preferred Experience
- Corporate Standard Gap Assessments for Quality Control related procedures.
- Support regulatory agency filings, inspections, and internal audits.
- Review of production records ensuring quality and proper cGMP documentation.
- Perform Raw Material and Product disposition and release.
Your experience and qualifications
- BS/BA in life sciences required; MS/PhD in life sciences preferred.
- Strong technical written and oral presentation skills.
- Experience in the review of analytical data from software such as SoftMax, Empower
- Knowledge in Quality Compliance (cGMP/ICHIFDAIUSP/EP policies/guidelines) required.
- 7+ years pharmaceutical QC/QA experience, with 4+ years QA specific experience.
- Experience in people management preferred.
- Experience in development of Biopharmaceutical/Biologics/Large Molecule products preferred.
- Experience with Microsoft Office Software.
- Familiar with biopharmaceutical operations and cGMP documentation practices.
- Experience with SAP, LIMS, and TrackWise a plus.
Enjoy a more rewarding choice
We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance.
Reports To
Amy Fluck
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva's Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
This position is not eligible for sponsorship. To be considered for this opportunity, you must apply on our career page.
