Quality Assurance Manager - OSD Facility

About Immacule Life Sciences

Established in 2012, Immacule Lifesciences has earned a reputable standing within the pharmaceutical sector. Our dedicated scientific team offers tailored services employing a broad array of resources and capabilities globally. As an end-to-end pharmaceutical service provider and collaborator, we emphasize quality, rapid delivery, and cost-efficiency by leveraging our technical expertise.

Our integrated pharmaceutical R&D pipeline covers from classification, development to commercialization of sophisticated liquid (both aqueous and non-aqueous) and lyophilized injectables, including preparations in vials and ampoules. We also possess strong competencies in terminal sterilization and aseptic injectable filling.

Functioning as a CDMO, we are swiftly gaining ground in the competitive sterile US marketplace—with our collaborators achieving 37 ANDA approvals, 18 ANDAs under review, and aiming for over 50 filings by 2025. Our focus lies on First to File 505(b)(2) submissions, novel chemical entities, complex generics niche products scale-up, exhibit batches, and commercial manufacturing support for an international clientele.

Role & Responsibilities

• Hold complete accountability for establishing, implementing, and maintaining compliance with the Quality Management System (QMS).
• Examine and authorize quality documentation such as Standard Manufacturing Forms (SMF), Validation Master Plans (VMP), Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMR)/Batch Packaging Records (BPR), product specifications, validation and qualification records, calibration, and preventive maintenance schedules.
• Oversee and approve handling of customer complaints, change control procedures, out-of-specification (OOS)/out-of-trend (OOT) results, product recalls, mock recalls, and related regulatory disclosures.
• Ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory mandates; make decisions for release or rejection of materials and finished products.
• Administer and review Corrective and Preventive Actions (CAPA), investigations, risk assessments, data integrity, and overall QMS activities.
• Guarantee effective execution of In-Process Quality Assurance (IPQA), validation, stability studies, self-inspections, and internal audits.
• Approve Technical and Quality Agreements and supervise contract manufacturers, vendors, and third-party laboratories.
• Assure preparedness of the manufacturing plant for regulatory, client, and GMP inspections, including prompt resolution of audit observations.
• Lead the adaptation and enforcement of regulatory/pharmacopoeial updates and quality prerequisites related to new product launches and technology transfers.
• Organize and facilitate Quality Review Meetings, ensuring all QMS tasks are concluded timely.
• Formulate the Quality strategy and cultivate a robust quality-oriented culture throughout the company.
• Direct, mentor, and coordinate the QA department, addressing manpower planning, task distribution, Key Result Areas (KRAs), and performance evaluations.
• Secure sufficient human resources, budget, and other necessary capabilities for efficient Quality department operations.
• Promptly escalate and communicate critical quality challenges to senior management.

Preferred Candidate Profile

• Applicants must hold a Bachelor of Pharmacy degree in any specialization.