Quality Systems Manager

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:

This is an exciting opportunity to lead the Veranova Quality Systems & Compliance team. The Quality Systems Manager will oversee the compliance function and related processes for the multi-site New England region. The position manages and provides direction to Quality Systems and Compliance staff, ensuring that processes and activities are performed in compliance with company policies, procedures, standards and applicable local, state, federal, and international regulations relating to the manufacture of active pharmaceuticals (APIs) and intermediates. This role will partner with various internal and external cross-functional teams as well as external regulatory and auditing agencies.

Core Responsibilities:

• Oversee the management of the Quality Systems & Compliance team supporting complaints, Annual Product Quality review, internal audit program, inspection readiness, Quality metrics, change management, quality events, supplier quality, environmental monitoring and Quality Management Review (QMR).
• Process owner for Quality Systems Management processes including Quality Events, quality metrics, change management, complaints, and document control. Lead or actively participate in implementation of updates and enhancements to these processes.
• Provide project and Subject Matter Expert support for all activities involving modifications, upgrades and or business process changes related to Quality Systems tools and applications.
• Develop and implement ways to improve Quality Systems business processes and strategies, which increase efficiency, improve compliance, and reduce system maintenance requirements.
• Partner with the IT organization to manage initiatives related to Quality Management Systems.
• Responsible for inspection readiness and manage regulatory inspection processes relating to cGMP including, but not limited to, FDA, MHRA, EMA, Health Canada, and Notified Body, across multiple sites. May act as key liaison for local, state, federal, and global regulatory agency inspections.
• Participate and coordinate FDA inspections, audits, and inspections by other regulatory agencies. Lead customer quality audits, including audit responses and share voice of customer with extended compliance systems peers from other sites.
• Develop and manage the internal auditing program to ensure a constant state of compliance. Plans and executes compliance audits of internal operations as they relate to GxPs to ensure compliance with policies, procedures, and regulatory requirements; drives timely completion of associated corrective actions. Track and trend multi-site compliance issues to assure alignment with corporate standards.
• Respond in a timely manner to compliance concerns and contribute to problem resolution.
• Manage the creation and maintenance of compliance metrics, development of trend data of audit / inspection observations and quality events, and communication of results expediently to applicable groups.
• Identify areas of improvement and participate in process improvement initiatives. Implements quality and process improvements evaluating multiple perspectives. Create new processes aimed at continual improvements, supporting a LEAN company culture.
• Aid in the harmonization and maintenance of harmonization of the Quality Management Systems across sites, updating procedures, decision trees and compliance tools for the site, as needed.
• Responsible for driving functional excellence though the tactical execution of improvement activities.
• Manage the range of performance management processes for direct reports.
• Other duties as assigned.

Qualifications:

Required

• Minimum 11 years of quality assurance and quality systems experience with an undergraduate degree in engineering, science or related field
• Minimum 9 years of quality assurance and quality systems experience with an graduate degree in engineering, science or related field
• Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry
• Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements
• Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance
• Have previous experience auditing for cGMP compliance
• Experience with project management and gap assessment projects
• Experience creating metrics for driving continuous improvement
• Excellent analytical, written and verbal communication and presentation skills
• Experience driving complex projects with the ability to initiate, prioritize, and successfully complete tasks
• Proven experience working effectively in team situations and as an individual contributor
• Demonstrated behavior that models the Veranova culture to achieve an inclusive environment and exceptional business results
• Previous people management and/or team leadership experience
• A mindset that promotes a positive work culture.

Preferred

• Certified Lead Auditor certificate, or certification(s) in Lean manufacturing methods/tools such as structured problem solving, Lean Six Sigma, etc.

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 misson to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit www.veranova.com to view all open roles and join our Talent Community to 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 to talentacquisition@veranova.com in 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: @veranova.com.
• 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: pharm.hr@veranova.com (US) or UKHR@veranova.com (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 our privacy notice.