Head of Quality Assurance

Title: Qual­i­ty Assur­ance Leader
Depart­ment: GMP Man­u­fac­tur­ing (Live Bio­ther­a­peu­tic Prod­ucts)
Exemp­t/Non-exempt: Exempt
Job Loca­tion: South San Fran­cis­co, CA

Descrip­tion of Role

The Qual­i­ty Assur­ance Leader will be respon­si­ble for imple­ment­ing and scal­ing the qual­i­ty func­tion sup­port­ing Kan­vas Bio­sciences’ clin­i­cal-phase Live Bio­ther­a­peu­tic Prod­uct (LBP) man­u­fac­tur­ing facil­i­ty. This role bal­ances strate­gic lead­er­ship with hands-on exe­cu­tion and part­ners close­ly with Man­u­fac­tur­ing, Qual­i­ty Con­trol, Facil­i­ties, and Reg­u­la­to­ry Affairs to ensure sys­tems, doc­u­men­ta­tion, and day-to-day deci­sions align with glob­al reg­u­la­to­ry expec­ta­tions and inter­nal qual­i­ty stan­dards. This posi­tion is crit­i­cal to safe­guard­ing prod­uct integri­ty, con­t­a­m­i­na­tion con­trol, and patient safety.

Key Respon­si­bil­i­ties

This role is site-based and high­ly cross-func­tion­al. You will:

Qual­i­ty Man­age­ment Sys­tem (QMS)

• Design, imple­ment, and con­tin­u­ous­ly enhance a phase-appro­pri­ate QMS aligned with cGMP stan­dards, ISO ¹³⁴⁸⁵⁄₁₇₀₂₅ require­ments, and applic­a­ble glob­al reg­u­la­to­ry frameworks.
• Own and over­see doc­u­ment con­trol, change man­age­ment, and record reten­tion pro­grams to ensure data integri­ty and compliance.
• Review and approve qual­i­ty-crit­i­cal doc­u­men­ta­tion includ­ing SOPs, mas­ter batch records, deviations/​investigations, CAPAs, and relat­ed qual­i­ty records.

Com­pli­ance & Reg­u­la­to­ry Oversight

• Ensure ongo­ing com­pli­ance with FDA and oth­er applic­a­ble reg­u­la­to­ry require­ments for LBP manufacturing.
• Lead inter­nal audit and sup­pli­er audit pro­grams using qual­i­ty risk man­age­ment tools.
• Serve as inspec­tion host and pri­ma­ry point of com­mu­ni­ca­tion dur­ing reg­u­la­to­ry inspec­tions; dri­ve time­ly and effec­tive res­o­lu­tion of observations.
• Part­ner with Reg­u­la­to­ry Affairs on sub­mis­sions, prod­uct qual­i­ty doc­u­men­ta­tion, and com­pli­ance strategy.

Batch Release & Prod­uct Quality

• Review and approve batch records, QC test results, and Cer­tifi­cates of Analy­sis (CoAs) to sup­port com­pli­ant and time­ly prod­uct release.
• Per­form release of clin­i­cal prod­uct for admin­is­tra­tion in clin­i­cal studies.
• Part­ner with QC to assess out-of-spec­i­fi­ca­tion (OOS) results, devi­a­tions, and inves­ti­ga­tions, and deter­mine appro­pri­ate prod­uct disposition.
• Track prod­uct qual­i­ty trends and proac­tive­ly com­mu­ni­cate emerg­ing risks to exec­u­tive leadership.

Con­tin­u­ous Improvement

• Estab­lish, mon­i­tor, and report KPIs that reflect qual­i­ty per­for­mance across Man­u­fac­tur­ing and QC.
• Proac­tive­ly iden­ti­fy and imple­ment process improve­ments, tools, and sys­tems to sup­port com­pli­ance and oper­a­tional effi­cien­cy through­out clin­i­cal development.

Train­ing & Leadership

• Lead, men­tor, and devel­op QA team mem­bers while fos­ter­ing a cul­ture of account­abil­i­ty, trans­paren­cy, and con­tin­u­ous learning.
• Lead depart­ments in the cre­ation and con­tin­u­ous review of train­ing pro­grams to ensure ade­qua­cy and compliance.
• Man­age the train­ing pro­gram and deliv­er GMP/GDP/GCP train­ing and con­t­a­m­i­na­tion pre­ven­tion training.
• Serve as a sub­ject-mat­ter expert and part­ner to cross-func­tion­al teams on qual­i­ty and com­pli­ance matters.

Key Qual­i­fi­ca­tions

We are seek­ing an expe­ri­enced QA leader with a strong foun­da­tion in reg­u­lat­ed manufacturing:

• Bachelor’s or Master’s degree in Micro­bi­ol­o­gy, Biotech­nol­o­gy, Bio­pro­cess­ing, or a relat­ed sci­en­tif­ic field.
• 12+ years of pro­gres­sive QA expe­ri­ence in fer­men­ta­tion, phar­ma­ceu­ti­cal, or biotech­nol­o­gy environments.
• Deep knowl­edge of cGMP, GLP, ICH, ISO ¹³⁴⁸⁵⁄₁₇₀₂₅, and FDA reg­u­la­to­ry expectations.
• Strong under­stand­ing of ALCOA+ and data integri­ty principles.
• Expe­ri­ence imple­ment­ing or man­ag­ing elec­tron­ic QMS, LIMS, and/​or ERP systems.
• Demon­strat­ed suc­cess sup­port­ing audits, reg­u­la­to­ry inspec­tions, and com­pli­ance programs.
• Strong orga­ni­za­tion­al and com­mu­ni­ca­tion skills with the abil­i­ty to man­age mul­ti­ple pri­or­i­ties and com­plex issues with high atten­tion to detail.
• Proven abil­i­ty to pro­vide cross-func­tion­al lead­er­ship, main­tain align­ment, and deliv­er col­lec­tive oper­a­tional goals (strate­gic and hands-on).

Pre­ferred Skills

• Famil­iar­i­ty with micro­bial fer­men­ta­tion systems.
• Expe­ri­ence with qual­i­ty risk man­age­ment and con­t­a­m­i­na­tion con­trol strate­gies in micro­bial man­u­fac­tur­ing environments.
• Six Sig­ma, Lean, or equiv­a­lent con­tin­u­ous improve­ment certification.

Our Val­ues

1. We hire good peo­ple who are also great sci­en­tists. We val­ue integri­ty, hon­esty, ded­i­ca­tion, and sportsmanship.
2. We think like explor­ers. We embrace new fron­tiers with prepa­ra­tion, cre­ativ­i­ty, and effort.
3. We have a stead­fast com­mit­ment to the team. We sup­port each oth­er and believe our col­lec­tive tal­ent can solve any problem.
4. We believe there is pow­er in diver­si­ty. We cel­e­brate diverse back­grounds and view­points as strengths that fuel dis­cov­ery and culture.

How to Apply

Please send your resume or CV to colleen@​kanvasbio.​com