Senior Director, Quality Assurance (Drug Product)- Remote US

ARAVAS INC• PA, US, PA

2d•$220,000 - $245,000•Remote

About The Position

The Senior Director of Quality Assurance (QA) will oversee the Drug Product (DP), Finished Goods (FG), and Combination Product (CP) review and release processes, device oversight, and product complaint management. As the primary point of contact (SPOC), this leader will have direct oversight of Contract Manufacturing Organizations (CMOs) and partners, managing related deviations and investigations. On behalf of QA, the Senior Director of QA will identify risks, resolve issues, and escalate matters as necessary to ensure product quality for clinical and commercial. The Senior Director demonstrates strong independent judgment and expertise in quality assurance.

Requirements

Demonstrated knowledge and thorough understanding of commercial and clinical manufacturing, artwork and labeling, product complaints, device manufacturing, distribution quality, quality processes, US/EU/ ROW Health Authority regulations, and industry standards such as ICH, WHO and RX360 for the pharmaceutical industry.
Continually evaluates and interprets regulatory standards and ICH guidelines to provide insight into current processes and recommends updates as appropriate.
Extensive experience in a virtual manufacturing environment.
Biologics technical understanding is required.
Excellent verbal, written, and presentation communication skills, ability to collaborate with cross-functional teams and independently prioritize work, build relationships, and manage multiple projects while maintaining quality and advocating compliance.
Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways.
Ability to deal with ambiguity, and provide creative and pragmatic solutions to issues and risks.
10+ years of progressive global quality/regulatory compliance background in pharma/biotech and medical device industries, with a hands-on role in quality operations and quality systems preferred
B.S./B.A. in a related discipline (STEM, pharmacy, medical, etc.) and 12 years of related experience or, M.S. in a related discipline (STEM, pharmacy, medical, etc.) and 10 years of related experience, or Ph.D. degree in a related discipline (STEM, pharmacy, medical, etc.) and 8 years of related experience

Nice To Haves

Small molecule and combination products is preferred.
Auditor certifications preferred.

Responsibilities

Assures compliance to cGMPs through review and lot disposition of Drug Product (DP) and Finished Goods (FG).
Provides appropriate Quality oversight of vendors and contract manufacturing organizations (CMOs) as it relates to lot disposition of DP/FG, identifying and resolving product quality issues and risks.
Provides support to ensure design control documentation and design change control requirements for combination products are complete and acceptable.
Provides support, review, and approval of clinical and commercial labeling.
Provides support, review, and approval of all clinical and commercial artwork.
Provides support, review, and approval of all QP-to-QP agreements.
Provides appropriate Quality oversight of the device CMO, identifying and resolving product quality issues and risks.
Accountable for the Product Complaint process, providing appropriate Quality oversight, resolution and maintaining metrics for both clinical and commercial supply.
Provides appropriate Quality oversight of distribution quality related to 3PLs (third party logistics) and works together with Supply Chain on product availability.
Reviews and approves manufacturing, testing, labeling/packaging, and other related documents for completeness and acceptability in a timely manner.
Authors and/or revises quality documents as required.
Partners with key stakeholders (e.g., Global Technical Operations, Clinical Operations, Clinical Development, Pharmacovigilance, Pharmaceutical Development, Regulatory Affairs) to work together on the analysis and interpretation of applicable GxP regulations.
Supports the administration of the company’s training program by assisting in the GxP training to internal departments and externally, as applicable.
Participates in inspection readiness and audits for key vendors, and coordinates responses to Health Authorities as necessary.
Participates in generating and presenting metrics related to these areas of expertise.
Participates with the tracking GxP compliance audit trends and group metrics and presenting metrics driven data to upper management.
Aids in the review of regulatory submissions as necessary for clarity and compliance with current regulations.
Other duties and projects as assigned.