Manager/Associate Director of Quality Assurance

Employment Status: Full-Time

Company Overview: www.bioacehealthterapeutics.com

About BioAce Health Therapeutics

BioAce Health Therapeutics is a clinical-stage biotechnology company focused on discovering and developing peptide-based therapeutics to previously ‘undruggable’ targets for major unmet medical needs, particularly high mortality cancers. BioAce’s technology acts by disrupting specific protein-protein interactions required for the regulation of key oncogenic and immune-modulatory proteins at the transcriptional level, allowing for targeting of intracellular proteins previously viewed as 'undruggable' due to their lack of enzymatic activity or ligand binding.

The position:

BioAce is currently seeking an Associate Director of Quality Assurance to join our growing biopharmaceutical company developing peptide-based therapeutics for major unmet medical needs, including high mortality cancers. BioAce currently outsources clinical development activities and this position will play a key role in the quality management of external partners.

Responsibilities:

• Development and maintenance of GXP quality systems and procedures that ensure compliance with established standards and agency guidelines (FDA, MHRA EU, ICH).
• Represent BioAce Quality both internally (e.g., clinical operations, regulatory, CMC, non-clinical) and externally (e.g., CRO’s, Vendors, Investigator Sites).
• Manage and maintain the vendor qualification process (GLP, GCP, GMP) including audits.
• Initiate new, revise existing, and conduct training of SOPs.
• Ensure documents are reviewed for completeness, accuracy, and conformance to GXP procedures and internal SOPs.
• Perform QA review of cGMP-related documentation, such as specifications, test methods, validation and technical protocols and reports, stability protocols and reports, master and executed production records, deviation/investigation/out-of-specification reports.
• Perform Quality investigations of events or deviations.
• Support development and maintenance of Quality Agreements with suppliers/partners.
• Manage quality systems such as document control, training, CAPA, and change control.
• Participate on cross-functional teams in support of new drug product development.
• Perform ad-hoc work/special projects as necessary to support BioAce Health Therapeutics.

Qualifications:

• Bachelor’s Degree or higher in biology, chemistry, or related life-sciences discipline; Master’s Degree preferred.
• Minimum 8 years of experience in quality assurance or related field within the pharmaceutical or biotech industry experience and at least 5 years of direct experience in GXP.
• Thorough knowledge of global rules, regulations, and guidances governing quality and safety of drugs and biologics in all phases of clinical development.
• Excellent communication skills required, both verbal and written.
• Effective leadership, negotiation, and conflict resolution skills.
• Strong attention to detail with ability to analyze, interpret, and solve complex problems.
• Self-motivated with ability to work independently and operate effectively within an entrepreneurial fast-paced team environment.
• Strong time-management and organizational skills with the ability to be flexible to meet set goals and timelines.
• Strong knowledge in standard software including MS Office Word, Excel, and PowerPoint.
• Full COVID-19 vaccination required.
• This role can be remote, but local candidates are preferred.
• Position may require some limited travel, 5%.

Contact: Please send resumes to careers@bioacehealthterapeutics.com