Overview
Quality Control Inspector – Piping (Night Shift) Jobs in Houston, TX at Enerflex Ltd
Role Overview
The Director/Senior Director of Quality Assurance (QA) would be responsible for aspects related to the Drug Substance (DS) QA review and release. As the single point of contact, this leader will be responsible for direct oversight of CMOs and partners, including associated deviations and investigations. Additionally, this position would represent QA to identify risks, resolve issues, and escalates appropriately to ensure product quality. This leader should demonstrate a high level of independent quality judgement and acumen.
Core Responsibilities
Assures compliance to cGMPs through review and lot disposition of Drug Substance (DS).
Provides appropriate Quality oversight of vendors and contract manufacturing organizations (CMOs) as it relates to lot disposition of DS, identifying and resolving product quality issues and risks.
Provides appropriate Quality oversight of raw materials, in process materials and any intermediates, identifying and resolving product quality issues and risks.
Accountable for investigating deviations and determining level of severity and generating a Savara deviation if required.
Provides appropriate Quality oversight, resolution and maintaining metrics for both clinical and commercial supply.
Reviews and/or approves batch records, deviations, 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.
Serves at CMC member, supports analytical control strategy and aids in the review of regulatory submissions as necessary for clarity and compliance with current regulations.
Required Skills/Experience
Demonstrated knowledge and thorough understanding of commercial and clinical manufacturing, quality systems such as deviations, CAPAs, 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. Small molecule and combination products is a plus.
Excellent verbal, written, and presentation communication skills, ability to work with cross-functional teams and independently prioritize work, 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.
Auditor certifications preferred.
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
B.S./B.A. in a related discipline (STEM, pharmacy, medical, etc.) and 15 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
Work Schedule and Location
This role will be remote within the United States. Occassional travel to the corporate office outside of Philadelphia, PA and vendor locations domestically and internationally will be required. The employee must be able to work a US eastern time schedule.
Savara provides Comprehensive Benefits including:
Highly competitive medical, dental, and vision coverage
Flexible Spending Accounts for health care and dependent care expenses
Paid time off and paid holidays, including Dec 24-Jan 1
Paid parental leave
401k with highly competitive match
Life, AD&D, STD and LTD insurance coverage
Savara’s compensation can include a base salary, bonus, and equity. This role can be filled either as a Director or Senior Director and the base salary range is $200,000 to $230,000.
About Savara
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company’s lead program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara’s management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.
Title: Quality Control Inspector – Piping (Night Shift)
Company: Enerflex Ltd
Location: Houston, TX
