Catalent Pharma Solutions

Specialist – Quality and Compliance

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

The Quality & Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support initiatives, supplier quality management, and process validation activities.

This is a full-time on-site position, Monday - Friday, 8:00am to 5:00pm.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role:

• Oversees customer Quality Agreements, including facilitating the development and approval of the agreements, ensuring accessibility of the agreements, and coordinating the revision and review of agreements.

• Supports customer audits, including coordinating audits with the customer and internal stakeholders; hosting audits and providing accurate information regarding the quality systems and operations; overseeing the audit response and follow up actions.

• Maintains facility licenses and registrations, and files and maintains controlled documents.

• Organizes documentation and facilitates review in support of client regulatory submissions.

• Monitors and assesses changes to regulatory guidance and compendial monographs.

• Supports and enhances effectiveness of the quality system, including reporting metrics; authoring Standard Operating Procedures (SOPs); identifying improvement opportunities; assisting with change control, risk management, and corrective and preventive action processes.

• Supports alignment and improvement initiatives, participating on cross-functional teams to address process improvement, system improvement, and new regulations/expectations.

• Drafts and executes technical plans, protocols, control strategies, and reports related to process validation and process monitoring (e.g., PPQ, CPV, APR / PQR).

• Maintains statistical tools to meet requirements for system and process monitoring and review.

• Maintains a sufficient understanding of the quality systems and operations to provide oversight and decision making.

• Other duties as assigned.

The Candidate:

• Requires Doctorate Degree in STEM discipline with minimum of 0 years related experience OR

• Master’s degree in STEM discipline with minimum of 4 years related experience OR

• Bachelor's Degree in STEM discipline with minimum of 6 years related experience OR

• Associates Degree in STEM discipline with minimum of 10 years related experience.

• Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines.

• Ability to use Excel, Word, and other office systems.

• Detail-oriented and well-organized with the ability to work effectively under high pressure with multiple deadlines and have the ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions.

• Ability to formulate and review complex and comprehensive materials.

• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• 152 hours of paid time off annually + 8 paid holidays

• Competitive salary with yearly bonus potential

• Community engagement and green initiatives

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .