Quality Assurance Deviations Lead
Quality Assurance Deviations Lead
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1 Vacancy
Job Description
Who We Are:
At Veranova we believe people are our most important asset and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising focus on quality compliance safety and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth and a desire to make a difference.
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility we develop solutions and processes that support and accelerate innovation.
Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.
Role Overview:
The QA Deviations lead will oversee the investigation documentation oversight and resolution of deviations to ensure compliance with regulatory standards internal policies and industry best practices. The ideal candidate will bring expertise in deviation investigations for CGMP manufacturing and testing an understanding of chemical processes for intermediates and APIs a proactive problem-solving mindset a coaching mindset and a commitment to maintaining the highest standards of product quality and safety. This role is both a hands-on role and an oversight role for deviations.
Core Responsibilities:
- Provide oversight on open deviation records and ensure owners are progressing and closing on time as defined by site procedures.
- Ensure consistent quality of investigation records root cause investigation report writing and CAPA/Effectiveness Check development for deviations in collaboration with cross-functional teams.
- Draft review and approve deviation reports ensuring accuracy completeness and compliance with Current Good Manufacturing Practices (CGMP) and other applicable regulations (e.g. FDA EMA).
- Develop and implement corrective and preventive actions (CAPAs) to address identified issues and mitigate recurrence.
- Provide guidance and training to QA team members and operational staff on deviation management processes.
- Lead the Deviation and CAPA board to routinely monitor the status of open deviations and CAPAs.
- Maintain and update deviation tracking systems ensuring timely closure of investigations and documentation.
- Collaborate with manufacturing engineering and quality control teams to identify trends and recommend process improvements.
- Present a review of deviation root cause trends and system metrics for Management Review meetings at the site and corporate level.
- Support internal and external audits by preparing deviation-related documentation and participating in audit responses.
- Ensure all activities align with company SOPs regulatory requirements and quality objectives.
- Aid in the harmonization and maintenance of harmonization of the Quality Management Systems for deviations across sites updating procedures decision trees and compliance tools for the site as needed.
- Participate in FDA inspections audits and inspections or in client audits as needed as an SME for the Quality System for deviations.
- Educate staff on best practices including new hire quality orientation and compliance training.
- Other duties as assigned.
Qualifications:
- Bachelors degree in a scientific or technical field (e.g. Biology Chemistry Engineering) or equivalent experience.
- 3 years of experience with deviation management in a regulated industry (pharmaceuticals biotech or medical devices preferred).
- In-depth knowledge of CGMP ICH guidelines and regulatory standards (e.g. 21 CFR Part 11 ISO 13485) governing deviations.
- Proven experience leading complex investigations and writing detailed technical reports.
- Strong analytical skills and proficiency with root cause analysis tools (e.g. 6M 5 Whys Fishbone).
- Excellent communication and interpersonal skills with the ability to work effectively in a team-oriented environment.
- Excellent technical writing skills and the ability to clearly express ideas in English.
- Proficiency in quality management software (e.g. TrackWise Veeva MasterControl).
- Able to successfully interface with internal and external customers.
- Ability to work independently and in a team environment.
- Experience with Microsoft Office applications including Word Excel and PowerPoint at a minimum.
Preferred
- Certification as a Deviation Investigator/Reviewer
- Experience creating metrics for driving continuous improvement
- Experience working in drug substance manufacturing
Our Commitment:
- Health & Wellness: Comprehensive health & Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
- Financial Wellness: Comprehensive total compensation package that includes competitive base salary Defined Contribution Pension program eligibility for performance-based bonuses and attractive 401(k) Plan with company match.
- Professional Development: Opportunities for continuous learning through LinkedIn Learning workshops conferences and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
- Inclusive Culture: At Veranova an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.
How to Apply:
At Veranova we are on a mission to meet people that believe in our values and can contribute to the team in a variety of ways. Please visitto view all open roles and join ourTalent Communityto stay connected and learn about opportunities as they arise.
We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients we encourage you to apply regardless of whether you meet every qualification listed.
If you are a veteran first responder or in the process of transitioning from service member to civilian life we encourage you to apply. Your experience brings invaluable skills and insights that can contribute to our team.
For applicants who may require a reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email toin order to confirm your request for an accommodation. Please include the job number title and location of role. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Veranova employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Additional Information:
Applicants for this role must be authorized to work in the United States without further employer sponsorship.
Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.
Important Notice Regarding Recruitment Scams: Veranova is committed to providing a professional and secure recruitment experience for all applicants. Unfortunately fraudulent job postings and recruitment scams are becoming more prevalent. We want to ensure that all candidates are aware of potential scams. Please see our notice here.
- Legitimate communications from Veranova will only come from official email addresses using our domain: @.
- Legitimate LinkedIn communications will only come from active Veranova employees.
- Veranova will never ask candidates for sensitive personal information during the application process (e.g. bank account details or social security number).
- Veranova will never ask candidates for payment (e.g. for equipment training or background checks).
If you have any doubts or concerns about the authenticity of a job posting please reach out to our HR department: (US) or (UK).
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age race color national origin religion sex sexual orientation gender identity and/or expression physical or mental disability genetic information citizenship marital status veteran status or any other characteristic protected by federal state or local law.
All applications are carefully considered and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view ourprivacy notice.
Employment Type
Full-Time
