Sr Director, External Quality Testing Operations

Senior DirectorExternal Quality TestingOperations

This role can be based in Foster City CA or Parsippany NJ

Gilead Sciences Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day you will be part of a team that is changing the world and helping millions of people live healthier more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions where every individual matters and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that arebenefitinghundreds of thousands of people a pipeline of strong late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Working inPDM GlobalQualityat Gilead:

Pharmaceutical Development & Manufacturing (PDM) GlobalQuality delivers on Gileads commitment to bring life-changing therapies to patients through robust Qualityprocesses and systems. Our approach is agileinnovativeandcollaborativeand our teams are committed to thesuccessfuldelivery of safe life-changing therapies.

Job Summary:

Gilead SciencesPDM External Qualityis currently seekinga leader at the SeniorDirector levelto lead a team of over 50 Quality Professionals to provide quality oversight of GMP activities atGileads contracttestingorganization global network supportingtherelease stability and characterizationtestingto enableclinical and commercialproduct submissionreleaseand distribution.

• Being a member of the External Quality Leadership team the successful candidate is expected to work collaboratively with internal and external networks to continually improve Gileads oversight model ofcontracttestingorganization global network and ensuremanufactured products aresafe and effective.

• Thesuccessfulcandidate must have demonstrated leadership skills and extensive working knowledge ofmanagingoutsourcedtesting operations fromsite selection qualificationscheduling sample shipmentmonitor adherence to schedule performance as well as providing quality oversight for laboratory investigationsand ongoing monitoring of method performance capacity and technical capabilityat the contract testing laboratories.

• Thesuccessfulcandidate must have prior leadership experience at contracttestingorganizations or have extensive experience overseeing contracttesting organizations.

• Thesuccessfulcandidate must be extremely familiar with applicable regulations and requirements with outsourced operations and clarity of the role and responsibilities between market authorizationholderand contracttestingorganizations.

• Thesuccessfulcandidate must possess strong communication influencing and negotiation skills be able to evaluate options and trade-offs and utilize available resources to achieve the most positive impact to the business and be able to partner with leaders in different PDM functions including Product and Portfolio Strategy Global ManufacturingSupply Chain Regulatory CMC and the wider Quality organization to achieve business objectives.

• The successful candidate must have proven track records in leading different QualityControlfunctions in a biotech or pharmaceutical development environment and strong knowledge of cGMPlaboratoryquality system and have extensive experience in managing auditsinspectionsand health authority interactions.

Job Functions:

• Execute an integrated and sustainable external qualitycontrol testingstrategyfor Gileads clinical andcommercial products based on the value proposition for Gilead (Integrity Inclusion Teamwork Accountability Excellence) and available SMEs.

• Develop processes to communicatelearnings anddrive any relatedquality control testingactivities for Gileads clinical and commercial products in support of arobustcompliantmethodlifecyclemanagement program.

• Develop a process for exchange of lessons learned across multiple company representatives andidentifyopportunities for Gileads process improvements.

• Collaborate withTechnical andQuality leadership toidentifysolutions andprocesses andalign with key partners on implementation of new requirements.

• Implement continuous improvement initiatives to drivequalitycontrol testingprograms and ensure maximum productivity.Ensuringsystems are world-class and meet the needs of all internal and external constituencies with an emphasis on process quality productivity budget control and profitability.

• Develop implementandmonitorqualitycontrol testingprograms policiesand procedures to ensure compliance withGxPstandards corporate policies FDA EMAand other regulatory body regulations and guidelines.

• Set and drive compliance to department site and global KPIs.

• Evaluate all currentqualitycontrol testingsystems and processes and recommend and implementappropriate enhancementsandtrainingto ensure the achievement of Gilead long-termobjectives.

• Professionalorganization engagement and representation; benchmarking in industry networks.

• Provide guidance to the business teams on technical regulatory requirements and lead andassistwhere needed.

• Participatein different internal business and technical forumsas Qualitys voice forcontract testing organizationsoversight.

• Conduct regular review and assessment ofregulatory intelligence and communicate any concerns trends gaps alerts to Quality management in a timely fashion.

• Think and act globally toanticipatepotential problems and risks related to regulatory compliance expectations.

• Approximately 20%travelis expected.

Knowledge Experience and Skills:

• Expert inquality requirementspertaining tooutsourcedtestingoperationsandcontract testinglaboratorydesignoperationsand maintenance with strong emphasis on data integrity.

• In-depth understanding and application of GMP principles concepts best practicesand standards in the USand internationally.

• Demonstrated ability todevelop and improve complex concepts techniquesandstandards and new applications based on quality principles and theories.

• In-depthknowledgeofGlobal requirements/standards for product registration and life-cycle management of product qualitycontrol testing.

• Demonstrated ability to developsolutions to complex problems which require a high degree of ingenuity creativity and innovativeness and where precedent may not exist.

• Excellent verbal written and interpersonal communication skills.

• Abilityto interactwith regulatory agenciesisneeded andpossessesthe ability torepresentGilead in public forums.

• Demonstratedexperience and ability to manageteamof highly technicalstaff.

• Expert inmanagingresources to address competingprojectsandtimelines.

Basic Qualifications:

• 12 - 15 years of relevant experience and abachelors degree in scienceor related fields;or8 years of relevant experience and an advanced science degree such as MS MD PharmD PhD or an advanced business degree such as an MBA.

• Priorleadershipexperiencein a complex organizationa must.

• Expert knowledge intechnical and regulatory requirementspertaining tolaboratory controls and outsourcedtestingoperationsisa must.

• Biopharmaceutical or Pharmaceutical experiencea must.

• Prior experienceleading contracttestingoperations oroverseeing contracttestingoperationsis a must.

• Experience withtesting operations indifferent pharmaceutical modalities e.g. parenteral biologicsoral solid dosageand medical devicepreferred.