DIRECTOR QUALITY ASSURANCE

Job Description The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients (API), biologics, vaccine drug substances and finished products.
As Director, you will support Quality audits and health authority inspections and ensure any resulting corrective and preventative actions (CAPA) are effectively implemented.
Primary Activities Serve as a subject matter expert for current good manufacturing practice (CGMP) requirements for vaccine and large molecule manufacturing Partner with our Company and CMO management to identify appropriate CAPA to address findings identified during audits and inspections.
Monitor CAPA status and ensure CAPA are implemented in accordance with commitments.
Perform independent verification of CAPA implementation and effectiveness to ensure no recurrence of findings Gather regulatory intelligence and partner with our Company and CMO management to prepare sites for audits and inspections.
Assists sites during audits and inspections to ensure successful outcomes Monitor and analyze the outcomes of audits and inspections to identify, investigate, and resolve trends.
Report results to Divisional and Regional Quality\/Management councils Provide guidance and consultation services for regulatory reporting (e.
., BPDR, DPR) Author and\/or review global standards and procedures related to biologics, vaccines, and finished product ensuring compliance with regulatory requirements Actively participate in industry organizations such as PDA, PQRI, PhRMA, ISPE, etc.
Education and Required Experience.
Bachelors degree in Life Sciences, Chemistry, Engineering or related relevant discipline and 10+ years of demonstrated experience within Quality compliance within large molecule manufacturing industry Expert knowledge of GMP requirements for multiple regulatory agencies Expert knowledge of large molecule manufacturing processes (for biologics and\/or vaccines) and sterility assurance requirements Ability to accurately interpret and apply regulatory expectations for a robust and compliant QMS Experience in health authority inspections Required Skills.
Drive Results - set clear performance standards, overcome obstacles; accountable for actions and achieve results Make Rapid, Disciplined Decisions - demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions Act with Courage and Candor - ability and willingness to advocate for compliance position using objective evidence, escalates issues and decisions, as appropriate Foster Collaboration - ability to influence, facilitate groups with diverse perspectives, bring teams to consensus\/alignment Make Rapid, Disciplined Decisions - demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions Act with Courage and Candor - ability and willingness to advocate for compliance position using objective evidence, escalates issues and decisions, as appropriate Preferred Skills\/Experience.
Experience working for a health authority as an inspector, investigator, compliance officer, reviewer, or assessor Experience creating or assessing remediation plans #EBRG Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only.
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Hybrid Work Model Effective September , employees in office-based positions in the U.
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will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.
his Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely.
Please note, this Hybrid work model guidance also does not apply to roles that have been designated as \