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Clinical Quality Assurance Manager- Pharmaceutical
Company | Teva Pharmaceuticals |
Address | , West Chester, 19380 |
Employment type | |
Salary | |
Expires | 2023-10-10 |
Posted at | 8 months ago |
Clinical Quality Assurance Manager- Pharmaceutical
Who we are?
The opportunity
As a Clinical Quality Assurance Manager at Teva Pharmaceuticals, you will be responsible for ensuring the highest standards of quality and compliance in all clinical operations. You will play a critical role in maintaining regulatory compliance, overseeing GxP processes, and fostering a culture of quality within the organization. Your attention to detail, strong knowledge of GCP and regulatory requirements, and ability to build partnerships will be essential in achieving operational excellence and delivering safe and effective pharmaceutical products.
This position is open in Parsippany, NJ or West Chester, PA
How you’ll spend your day
- Conduct audits and inspections of internal processes, vendors, and external partners to assess compliance and identify areas for improvement.
- Foster strong partnerships with internal stakeholders, including Clinical Operations, Regulatory Affairs, and Pharmacovigilance, to ensure effective collaboration and information sharing.
- Collaborate with cross-functional teams to develop, implement, and maintain quality systems and processes to support clinical operations.
- Ensure compliance with GCP regulations and guidelines, including oversight of clinical trial activities and documentation.
- Drive continuous improvement initiatives to optimize quality systems, streamline processes, and mitigate risks.
- Develop and deliver training programs on quality assurance topics to enhance staff knowledge and compliance awareness.
- Stay abreast of regulatory requirements, industry best practices, and emerging trends in clinical quality assurance.
- Act as a change agent, identifying opportunities for process improvements and implementing new technologies to enhance quality and efficiency.
- Represent Teva Pharmaceuticals during regulatory inspections (e.g., FDA, MHRA, EMA) and coordinate responses to findings and observations.
- Provide guidance and support to project teams in interpreting and implementing regulations, standards, and quality procedures.
Your experience and qualifications
- Solid understanding of GCP/ICH guidelines and the drug development process.
- Minimum of 3-5 years of experience in the pharmaceutical industry, with a strong understanding of GxP regulations and practices.
- Excellent change management skills, with the ability to assess readiness and implement appropriate opportunities for change.
- Strong attention to detail with the ability to prioritize tasks and meet aggressive deadlines.
- Self-motivated and capable of working with minimal supervision.
- Demonstrates a customer-focused approach and possesses excellent interpersonal, communication, and facilitation skills.
- Proficiency in Good Clinical Practice (GCP) guidelines and experience with regulatory inspections (FDA, MHRA, EMA, etc.).
- Bachelor's degree in a scientific discipline, with a preference for a healthcare-related field, or equivalent.
- Proven ability to build partnerships within a team and across functions in a large and complex global organization.
Join Teva Pharmaceuticals as a Clinical Quality Assurance Manager and contribute to the company's commitment to delivering high-quality pharmaceutical products that improve the lives of patients worldwide.
Reports To
Director Clinical Quality Assurance
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.
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.
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